2015 Education Brochure

Parenteral Drug Association U.S.
Education Courses
2015 PDA U.S. Education Courses

Where Excellence Begins
Laboratory and Classroom Training for Pharmaceutical

and Biopharmaceutical Professionals
M A R C H D E C E M B E R 2015
pda.org/courses

Check pda.org/calendar for an updated list of courses
Denotes Laboratory Courses
DATES
Denotes
COURSE NAME
1/26 1/30
2/23 2/27
Aseptic Processing Training Program, Session 1 | pda.org/2015aseptic1
3/9 3/13
Fundamentals of Aseptic Processing | pda.org/FAP1
3/19 3/20
2015 PDA Annual Meeting Course Series | pdannualmeeting.org/courses
3/19
Technical and Regulatory Challenges of Combination Drug Delivery Products

Pre-filled Syringes, Autoinjectors and Injection Pens
3/19
The Quality Culture and Its Measurement New Course
3/19
Applying Six Sigma Techniques to the Process Validation Lifecycle New Course
3/19 3/20
Sterile Pharmaceutical Dosage Forms
3/20
Developing a Robust Supplier Management Process
3/23 3/27
4/13 4/17
4/20 4/23
Train the Trainer Week | pda.org/trainer
4/20
Qualifying Your SMEs as Trainers
4/21 4/22
Learning, Knowledge Management and Impact: Moving from Theory to Practice
4/23
Designing/Presenting GXP Training Programs to Meet FDA Requirements
4/27 4/29
5/4 5/7
Lyophilization Week | pda.org/lyo

Fundamentals of Lyophilization
5/6 5/7
Validation of Lyophilization
5/13
SOLD OUT
SOLD OUT
Validation of Biotechnology-related Cleaning Processes | pda.org/biotechclean
5/4 5/5
5/11 5/12
LOCATION
Recommended Practices for Manual Aseptic Processes | pda.org/MAP

Risk Based Approach for Prevention and Management of Drug Shortages | pda.org/prevention
5/18 5/22
6/15 6/19
5/20 5/21
2015 PDA Pharmaceutical Packaging Course Series | pda.org/packagingcourses
5/20
Selection and Utilization of Glass Containers in Pharmaceutical Packaging
5/21
Implementing Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations:
Case Studies in the Packaging and Labeling of Drug Products
5/22
6/1 6/3
SOLD OUT
Technical Development of Prefilled Syringes, Autoinjectors and Injection Pens | pda.org/techdevelop

Immediately following the 2015 PDA Drug Delivery Combination Products Workshop
Management of Aseptic Processing | pda.org/apmanagement
TYPE
Bethesda, MD
Lab
Bethesda, MD
Lab
Las Vegas, NV
Lecture
Bethesda, MD
Lab
Bethesda, MD
Lecture
Bethesda, MD
Lab
Bethesda, MD
Lecture
Bethesda, MD
Lab
Bethesda, MD
Lecture
Bethesda, MD
Lab
Baltimore, MD
Lecture
Baltimore, MD
Lecture
Bethesda, MD
Lab
6/4
Process Simulation Testing for Aseptically Filled Products | pda.org/simulation
Bethesda, MD
Lecture
6/9 6/10
Fundamentals of Cleaning and Disinfectant Programs for Aseptic Manufacturing

Facilities | pda.org/cleaning
Bethesda, MD
Lab
6/11 6/12
2015 PDA Aseptic Processing Sterilization Course Series | pda.org/sterilizationcourses
San Diego, CA
Lecture
6/11
Process Simulation Testing for Aseptically Filled Products
6/11
Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Validation and Ongoing Control
6/12
Recommended Practices for Manual Aseptic Processes
6/12
Parametric Release of Pharmaceutical and Medical Device Products Sterilized with Moist Heat
6/25 6/26
2015 PDA Single Use Systems Workshop Course Series | pda.org/suscourses
Bethesda, MD
Assessing Packaging and Processing Extractables/Leachables
Lab
Lecture
Single Use Systems for the Manufacturing of Parenteral Products
7/7
Application of Phase-Appropriate GMP to the Development of Protein Bulk Drug Substances |

pda.org/bulkdrug
Bethesda, MD
Lecture
7/8
A Former Investigators Perspective on Conducting Effective Deviation Investigations, Root

Cause Investigations and Corrective and Preventive Actions (CAPA) | pda.org/capa
Bethesda, MD
Lecture
PDA U.S. Education Courses | M A R C H D E C E M B E R 2 0 1 5
Fundamentals of Aseptic Processing

March 9 13, 2015
PDA Training and Research Institute | Bethesda, Maryland

This 5-day laboratory course will provide you with an understanding of the fundamental principles governing aseptic processing,
focusing on the systems associated with aseptic processing and how they work together to help ensure a sterile product.
Upon completion of this course, you will be able to:

Outline the process steps involved in producing aseptically filled products

Describe how different aspects of aseptic processing are interrelated
Identify microorganisms of specific concern in controlled environments and their origins
Discuss your specific role in aseptic processing and how you fit in
Explain the process steps most commonly described as risky, and how you can manage those risks
Instructors:
Carol Lampe, Trainer and Consultant
Brent Watkins, Southeast Sales Manager, Veltek Associates Inc.
pda.org/fap1
pda.org/courses
Connecting People, Science and Regulation
2015 PDA Annual Meeting Course Series

March 19 20, 2015
Red Rock Casino, Resort and Spa | Las Vegas, Nevada

Immediately following the2015 PDA Annual Meeting, PDA will be offeringfive courses designed to complement what youve
learned at the conference.
Technical and Regulatory Challenges of Drug Delivery Combination Products

Prefilled Syringes, Autoinjectors and Injection Pens (March 19)
Examine the technical and regulatory challenges companies will face in the development and registration of Drug Delivery
Combination Products.Learn to initiate a gap analysis to identify the requirements and elements of a successful Drug Delivery
Combination Product development program. Proper implementation of these elements will minimize project risk.
Instructor:
Lee Leichter, President,P/L Biomedical
NEW COURSE
The Quality Culture and its Measurement (March 19)
This course will provide an opportunity to discuss the components of a quality culture, how to measure those
components and strategies for enacting change. Through a combination of lecture and small group exercises, this course will enable
you to evaluate your company culture and come up with ideas on how to improve it.
Prerequisites
Participants should read ICH Q10 and the article, The Quality Culture and its Measurement, by R. Kieffer. Class attendees are asked to
bring their thoughts and perspectives on their own companys culture.
Instructor:
Robert G. Kieffer, PhD, President, RGK Consulting
NEW COURSE
Applying Six Sigma Techniques to the Process Validation Lifecycle (March 19)
Review the fundamental steps in the Six Sigma process, discuss the use of risk assessments in assigning appropriate
sample sizes, and provide case studies in the appropriate data analysis across the lifecycle. The primary focus in this one-day course
will be on stage 2b Process Performance Qualification (PPQ).
Instructor:
Mike Long, Director, Consulting Services, ValSource, LLC
pda.org/courses
Sterile Pharmaceutical Dosage Forms: Basic Principles (March 19 20)

This introductory two-day course will address clean room design, environmental monitoring and control, sterilization principles,
manufacturing unit operations, aseptic filling, dosage form development, packaging and stability requirements, validation of aseptic
processing (media fills), product specific validation, QA/QC for parenterals, and regulatory trends.
Upon completion of this course, you will be able to describe the basic principles of clean room facility design, environmental monitoring,
and aseptic processing; summarize the current cGMP regulatory and inspection trends for parenteral manufacturing; and much more!
Instructor:
John Ludwig, Senior Vice President, Pfizer
Developing a Robust Supplier Management Process (March 20)

Determine appropriate level of control for suppliers based on risk and developing assessment methods and continuous monitoring tools.
Through discussion of best practices and current regulatory expectations, you will develop a better understanding of supplier selection,
evaluation and monitoring processes and will be able to apply these concepts within your own companys supplier management
process. At the conclusion of this course, you will be familiar with current regulatory expectations regarding supplier management and
be able to implement these concepts in your own company to reduce the risks associated with supplier management.
Instructor:
Lisa Hornback, Principal Consultant, Hornback Consulting, LLC
pdaannualmeeting.org/courses
pda.org/courses
2015 Aseptic Processing Training Program
Session 1: January 26 30 and February 23 27, 2015 SOLD OUT

Session 2: March 23 27 and April 13 17, 2015 SOLD OUT
Session 3: May 18 22 and June 15 19, 2015 SOLD OUT
Session 4: August 3 7 and August 24 28, 2015 SOLD OUT
Session 5: October 5 9 and November 2 6, 2015
By popular demand, a new fifth session of

the Aseptic Processing Training course has
been added. There are less than 22 spots
available and when they are full, there
wont be another opportunity until 2016.

Properly evaluate and improve your aseptic processes to ensure sterile products. This course provides the perfect balance of hands-on
laboratory and lecture training, equipping you with tools and practical experience you can bring home and apply immediately on the job.
Two five-day sessions allow for an in-depth look into a broad array of topic areas. These two sessions allow for intense, comprehensive
learning with minimal impact away from your job/organization.
This is the most complete aseptic processing training program offered with almost 50 hours of hands-on laboratory training and
group project work. In addition, there will be extensive coverage of topics during the lecture sessions, all delivered by a faculty with
more than 300 years combined experience in aseptic processing.
Early registration is recommended as the Aseptic Processing Training Programs tend to sell-out quickly!
Lead Instructors:
David Matsuhiro, Principal Consultant, Cleanroom Compliance, Inc.
Harold Baseman, Chief Operating Officer and Principal, ValSource, LLC
And, eighteen other industry leading experts!
pda.org/2015aseptic
pda.org/courses
Train the Trainer Week

April 20 23, 2015

Organizations are challenged with finding ways to do more with fewer employees, while at the same time, keeping up
with constant changes, regulatory updates and procedure revisions. PDA recognizes this struggle and has teamed up with
industry experts to help you and your company by providing training for the trainer to facilitate continuing education.
Qualifying Your SMEs as Trainers (April 20)

This course is designed to provide you with the minimum requirements necessary to develop a Trainer Qualification program in
house by focusing on the following topics:

Identification of SMEs
Organizational Readiness
What Belongs in a Department Trainers Curriculum
First-Time Observation of Trainers
Department Trainers Employee Qualification
Prerequisites
Participants are encouraged to review their current training processes/SOPs as they will be asked to reference them during the course.
Instructor:
Vivian Bringslimark, President, HPIS Consulting, Inc.
Learning, Knowledge Management and Impact: Moving from Theory to Practice (April 21 22)
In this course, key theories that describe knowledge management and how people learn will be examined. You will find ways to
apply these theories to some of the practical challenges faced in the pharmaceutical/biopharmaceutical industry, such as knowledge
acquisition and transfer, procedure writing and training, new employee on-boarding, web-based learning, and assessment and
evaluation. A large portion of this course will involve identifying best practices, both inside the industry and beyond, and using this
information, along with the groups experience and creativity, to reimagine what can be done differently.
Prerequisites
Participants should have familiarity with current training approaches (e.g., instructional design) and regulatory expectations. Prior to
the session, participants will be provided with a reading list of recommended resources.
Instructor:
James Vesper,President,LearningPlus, Inc
Designing/Presenting GXP Training Programs to Meet FDA Requirements (April 23)

Points to be covered include: reviewing past GMP training topics, conducting a needs analysis, selecting a topic tied to facility quality
objectives and FDA quality requirements, brainstorming creative approaches, developing the presentation, maximizing presentation
success, evaluating training effectiveness, and audit-proofing training documentation. Using individual and small group exercises,
you will leave with a new program well on the way to completion.
Instructor:
Elaine Lehecka Pratt, President, Lehecka Pratt Associates, Inc.
pda.org/trainer
pda.org/courses
Validation of Biotechnology-related Cleaning Processes

April 27 29, 2015

This course is ideal for anyone involved in cleaning validation for biotechnology manufacture. Attendees will be provided with a complete,
hands-on cleaning validation education program covering both automated (CIP) and manual cleaning for biotech manufacture.
This three-day course includes the use of a CIP skid, which helps the attendees understand everything from the impact of system
design on cleanability to how to take swab samples and set acceptance criteria. Participants will gain direct experience setting up
an effective cleaning program by going through a systematic approach to cleaning validation. The approach used includes initial
evaluation of the equipment to be cleaned, analytical techniques, worst-case conditions, multi-product cleaning, cleaning cycle
development, and validation of the cleaning process.
Instructor:
Rebecca Brewer, Director, Consultancy Services, Dober Group
pda.org/biotechclean
pda.org/courses
Source: Texwipe
Lyophilization Week
May 4 7, 2015

PDA has designed two courses to increase your knowledge on the fundamentals and validation of lyophilization processes.
Fundamentals of Lyophilization (May 4 5)

This course is designed for participants to develop an understanding of the basic principles and practical aspects of lyophilization
technology. Selected topics include an overview of cycles and equipment, vacuum technology use for freeze drying, sublimation
in primary drying, desorption during secondary drying, application of principles to product and process development, analysis
of product characteristics, and process scale-up to production. Upon completion of this course, attendees will have a working
knowledge for practical application in development, production, and evaluation of lyophilized parenterals.
Instructor:
Edward H. Trappler, President, Lyophilization Technology, Inc.
Validation of Lyophilization (May 6 7)

This course is designed to give participants an understanding of the requirements for qualification of a lyophilizer and validation
of lyophilization processes. In addition, participants will gain an understanding of the basic principles of lyophilization and the
techniques utilized in evaluation of lyophilized materials. The course format will include lecture and discussion of principles, as well as
case studies and examples.
Instructors:
Karen A. Bossert, PhD, RPh, Vice President, Scientific Affairs, Lyophilization Technology, Inc.
Barbara Berglund, Manager, QA, Royal Chemical
pda.org/lyo
pda.org/courses
Recommended Practices for Manual Aseptic Processes

May 11 12, 2015

This course provides valuable practical insights into the technological challenges associated with designing, operating and
evaluating manual aseptic processing. You will leave with an understanding of how manual and automated aseptic processes differ,
and what should be addressed as you work with manual aseptic processes in your own plants. This course will provide a lab-based
tutorial of suitable physical techniques, equipment use, and processing operations that can be used to address the challenges posed
in the design and control of manual aseptic processing. Topics such as personnel training and qualification, design of manual aseptic
processes and evaluation of manual aseptic processing process simulations will be covered. The course is based on a PDA Technical
Report addressing the same subject.
Instructor:
Olivia Henderson, PhD, Principal Scientist, Protein Pharmaceutical Development, Biogen Idec
pda.org/MAP
NEW COURSE
Risk Based Approach for Prevention and Management of Drug Shortages
May 13, 2015

This course is based on PDA Technical Report 68 and participants will learn how to apply a proactive risk-based model at a product
level to identify drug shortage risks due to manufacturing and quality issues. Attendees will practice how to develop a Drug Shortage
Risk Register and a Drug Shortage Prevention and Response Plan using examples and standard templates.
Instructors:
Emma Ramnarine, Senior Director, Head Global Biologics QC, Genentech
Stephan Rnninger, Head External Relations Europe, International Quality, Amgen (Europe GmBH)
pda.org/prevention
10
pda.org/courses
pda.org/courses
11
2015 PDA Pharmaceutical Packaging Course Series

May 20 21, 2015
Four Seasons Hotel Baltimore | Baltimore, Maryland

On May 20-21, immediately following the 2015 PDA Pharmaceutical Packaging Conference, PDA will be hosting two courses
designed to complement what you learned at the conference. These courses will use a combination of lecture and
interactive learning to provide you with more detailed information on the selection of glass containers in pharmaceutical
packaging and in the packaging and labeling of drug products.
Selection and Utilization of Glass Containers in Pharmaceutical Packaging (May 20)

The course will consist of both lecture and discussion of case studies pertaining to the compatibility of glass with drug products,
glass standards, glass handling during the pharmaceutical process, and regulatory requirements. Students will also learn how to write
specifications for glass components to obtain consistent, high-quality parts and learn how to identify points in their process that
can impact quality. The objective of this course is to give attendees a broad overview of the advantages and disadvantages of glass
containers based on the interaction of glass with drug products. Gain an appreciation of the methods that both glass suppliers and
pharmaceutical scientists can utilize to increase the compatibility of glass with drugs and reduce glass container defects.
Instructors:
Roger Asselta, Vice President, Technical Affairs, Genesis Packaging Technologies
Edward J. Smith, PhD, Principal Consultant, Packaging Science Resources, LLC
Implementing Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing

Operations: Case Studies in the Packaging and Labeling of Drug Products (May 21)
This lecture course will utilize the methodology of PDA Technical Report No. 54, Implementation of Quality Risk Management for
Pharmaceutical and Biotechnology Manufacturing Operations, to identify, assess, manage and use risk to make informed decisions in
packaging and labeling operations.
In addition, this course will provide participants with a systematic approach for recognizing and analyzing potential risks by
exploring case studies aimed at highlighting the different applications of quality risk management throughout the pharmaceutical
and biotechnology manufacturing operations in packaging and labeling. As there are many approaches that can be used for
implementation of the ICH Q9 guideline, the course will highlight among other aspects the various risk scoring criteria, emphasizing
the various uses of quality risk management across the industry and to point out that there is no one way of applying it.
Instructor:
Ghada Haddad, Director, Engineering, Sterile & Validation CoE, Merck and Company, Inc.
pda.org/packagingcourses
12
pda.org/courses
Technical Development of Prefilled Syringes, Autoinjectors and Injection Pens

May 22, 2015
Four Seasons Hotel Baltimore | Baltimore, Maryland

On May 22, immediately following the 2015 PDA Drug Delivery Combination Products Workshop, PDA will offer a continuing
education course, which will provide guidance and best practices for the design, development, manufacture, testing,
quality assurance and marketing strategy for drug delivery systems.
This course will provide guidance and best practices for the design, development, manufacture, testing, quality assurance and
marketing strategy for syringes, autoinjectors, pens and related drug delivery systems. Strategy and tactics for developing prefilled
syringes, autoinjectors and injection pens will be the primary focus. Setting up project management and design control processes
will also be covered. Participants will additionally have exposure to information on stability programs, syringability force testing,
human factor study, extractable/leachable and compatibility testing; Lectures, workshops, discussions and case studies will provide
the opportunity for both learning and practice.
Instructor:
Patty H. Kiang, PhD, Pharmaceutical Consultant, Kiang Consultant Services
pda.org/techdevelop
Management of Aseptic Processing

June 1 3, 2015

International regulatory authorities are placing a heavy emphasis on aseptic processing, and its difficult to keep pace with what
their expectations really are.Are you sure you know what constitutes current Good Aseptic Practices? Are you making sound
decisions about your aseptic operation?PDA is announcing its newest course in the area of Aseptic Processing Management of
Aseptic Processing.This course will arm managers with the tools they need to make informed business decisions related to aseptically
produced products, including selection of aseptic processing technologies, and sourcing decisions.
The instructors in this course will provide you with insight into current inspection trends so you can keep up with the moving target
of cGMP. Youll come away with an understanding of the spectrum of aseptic process designs and operations, and different risk
management strategies that should be employed for the most effective cost benefit result. Youll learn the science behind airflow,
aseptic technique, human factors, personnel qualification and tools like smoke studies, media fills and risk assessments.
Do you have the right people in your organization? The right culture? How are you going to recognize the need for, implement, and
manage changes within your organization?The course will provide you with the knowledge needed to evaluate investigations, and
make informed, risk-based decisions regarding product disposition.
Make sure you and your company remain on the positive side of current and anticipated expectations in the industry by ensuring
high-quality products through sound scientific practices, good decision making, and an efficient and effective team.
Instructors:
Rainer Newman, Independant Expert and Consultant, Aseptic Process Technology, LLC
pda.org/apmanagement
pda.org/courses
13
Process Simulation Testing for Aseptically Filled Products

June 4, 2015

This course will address all the various elements required in the design and execution of a media fill, including personnel qualification,
media selection and preparation, filling considerations, interventions, duration and number of units filled, pre and post incubation
inspections, incubation conditions, acceptance criteria and investigations and corrective actions. The use of risk-based decision
making will be considered. Participants in this course will come away with an up-to-date understanding of current scientific and
regulatory advances in the design, conduct and interpretation of process simulations. The knowledge they gain can be applied
immediately to media fill operations in their own jobs.
Instructor:
pda.org/simulation
Fundamentals of Cleaning and Disinfectant Programs for Aseptic

Manufacturing Facilities
June 9 10, 2015

This course covers the critical steps to developing and validating a complete contamination control program within controlled and
non-controlled environments using chemical agents that reduce or destroy microorganisms. While sterile product manufacturing
requires the most stringent application, the concepts introduced during the course can also be used to design a program for the
manufacture of non-sterile products. The important aspects of the soon-to-be-released Cleaning and Disinfection Technical Report
from PDA will also be highlighted.
Instructor:
Art Vellutato Jr., President, Veltek Associates Inc.
pda.org/cleaning
14
pda.org/courses
2015 PDA Aseptic Processing Sterilization Course Series

June 11 12, 2015
Loews Coronado Bay Resort | San Diego, California

Expand your knowledge at the 2015 PDA Aseptic Processing Sterilization Course Series. Four courses have been developed
to educate you on everything from process simulation testing to parametric release.
Process Simulation Testing for Aseptically Filled

Products (June 11)
Recommended Practices for Manual Aseptic

Processes (June 12)
This course will address all the various elements required

in the design and execution of a media fill, including
personnel qualification, media selection and preparation,
filling considerations, interventions, duration and number of
units filled, pre- and post-incubation inspections, incubation
conditions, acceptance criteria and investigations and corrective
actions. The use of risk-based decision making will be considered.
Participants will come away with an up-to-date understanding of
current scientific and regulatory advances in the design, conduct
and interpretation of process simulations. The knowledge gained
by the course participants can be applied immediately to media
fill operations in their own jobs.
This course will provide valuable, practical insights into the

technological challenges associated with designing, operating
and evaluating manual aseptic processing. Participants will come
away with an understanding of how manual and automated
aseptic processes differ, and what should be addressed as they
work with manual aseptic processes in their own plants. They will
also learn how process simulation testing to evaluate manual
aseptic processing operations should be designed and carried
out. Topics such as personnel training and qualification, design
of manual aseptic processes and evaluation of manual aseptic
processing process simulations will be covered.
Instructor:
Marsha Stabler Hardiman, Senior Consultant, Concordia
ValSource, LLC
Validation of Moist Heat Sterilization Processes:

Cycle Design, Development, Validation and
Ongoing Control (June 11)
This course will provide a foundational understanding of
sterilization science (microbiology and thermal science) that
will then be applied in the selection of a cycle design approach,
sterilization process development, process performance
qualification and ongoing process control. Important moist
heat sterilization topics also covered by this course include:
considerations in the use of steam and water requirements for
moist heat processes, fundamentals in the selection and use
of biological indicators and chemical indicators, selection of
a sterilization process type based on product attributes, and
design considerations for key and critical parameters.
Instructor:
Michael Sadowski,Director, Sterile Manufacture Support,
Baxter Healthcare
Instructor:
Olivia Henderson, PhD, Principal Scientist, Protein
Pharmaceutical Development, Biogen Idec
Parametric Release of Pharmaceutical and Medical

Device Products Sterilized with Moist Heat (June 12)
This course is designed to benefit organizations that are
pursuing development of a parametric release moist heat
sterilization program as well as organizations seeking to
improve conventional moist heat sterilization programs. Global
parametric release requirements will be summarized along with
best demonstrated practices that can be utilized to efficiently
comply with these requirements. Topics will include the history
of parametric release, limitations of the sterility test, sterilization
science (microbiology and thermal science), essential elements
of a parametric release program, and recommended submission
content. Participants will also examine a case study on the
application of quality risk management.
Instructor:
Michael Sadowski, Director, Sterile Product Manufacturing,
Baxter Healthcare Corporation
pda.org/sterilizationcourses
pda.org/courses
15
2015 PDA Single Use Systems Workshop Course Series

June 25-26, 2015

Bethesda North Marriott Hotel and Conference Center | Bethesda, Maryland
This course series builds on the content delivered at PDAs Single Use Systems Workshop when taken together. When taken
alone, it provides a comprehensive look at packaging and processing Extractables/Leachables and critical concepts to
consider when implementing a single use system strategy in a pharmaceutical manufacturing process.
Assessing Packaging and Processing Extractables/Leachables

Participants will review regulations regarding the reporting, identification, and measurement of extractables/leachables (E/L) from
packaging materials and product contact items used in drug processing. A detailed discussion on the sources of extractables from
materials, such as plastic, glass and rubber, will be included. E/L from packaging, and processing components/materials will also
be discussed. Attendees will be shown how to design and execute an E/L study. Attendees will be provided with a synopsis of the
current and anticipated regulations and a means to address the issues in a responsible, scientific, and cost-effective manner.
Instructors:
Cheryl Stults, PhD, Principal, C & M Technical Consulting, LLC
Edward J. Smith, PhD, Principal Consultant, Packaging Sciences Resources, LLC
Single Use Systems for the Manufacturing of Parenteral Products

This course will provide students with critical concepts to consider when implementing a single use system (SUS) strategy in a
pharmaceutical manufacturing process. These concepts are intended to be valid both for chemically synthesized small molecules and
for bioprocesses that produce large-molecule biopharmaceutical products.
SUSs that are in either direct or indirect contact with the raw materials, intermediates, intermediate products, pharmaceutical drug
substances or drug products will be discussed.
Determining the optimal manufacturing strategy involves concepts from many disciplines. An effective evaluation will have a
balanced viewpoint, with consideration from engineering, regulatory, quality, project management and accounting. Balancing risks
and rewards of an SUS over a Multiple Use System will help determine the most appropriate manufacturing strategy.
Instructor:
Robert Repetto, Senior Director, External Affairs, Pfizer, Inc.
pda.org/suscourses
16
pda.org/courses
Application of Phase-Appropriate GMP to the Development

of Protein Bulk Drug Substances
July 7, 2015

This course defines current Good Manufacturing Practice (cGMP) principles important for manufacturing therapeutic protein
drug substances for use in clinical trials (pre-marketing), and provides examples of approaches toward cGMP compliance during
clinical studies. An overview of PDAs Technical Report 56 is provided, which presents the expectations across regulatory authorities
as biopharmaceutical products proceed from the discovery/R&D stage through completion of phase 3 clinical trials. A phaseappropriate approach to the implementation of cGMP; an approach that enables sponsors to supply safe clinical materials for studies
in humans while maintaining manufacturing flexibility at non-commercial scales, during scale up and process transfer to commercial
facilities, will be introduced.
Instructor:
John Geigert, PhD, RAC, President, BioPharmaceutical Quality Solutions
pda.org/bulkdrug
A Former Investigators Perspective on Conducting Effective

Deviation Investigations, Root Cause Investigations and Corrective
and Preventive Actions (CAPA)
July 8, 2015

This introductory course will focus on a quality systems approach toward conducting deviation investigations in accordance with
FDAs current Quality Systems and cGMP compliance expectations. Participants will gain a former FDA investigators insight into FDAs
quality systems and compliance expectations associated with deviations (discrepancies), out-of-specification test results, and nonconformance investigations.
Upon completing this course, participants will have a clear understanding of the key elements that must be considered when
conducting deviation investigations, proposing corrective and preventive actions, and will understand the difference between
corrective vs. preventive actions. FDA compliance issues and concerns will also be addressed.
A combination of lectures and workshop/small group class exercise will be utilized to emphasize and highlight key points.
Instructor:
Jeff Yuen, MPH, President and CEO, Jeff Yuen & Associates Inc.
pdas.org/capa
pda.org/courses
17
Moist Heat Sterilization Week

July 21 23, 2015

Moist heat sterilization processes are considered to be special processes since the output of the process, product sterility,
cannot be fully verified with test methodologies such as the sterility test. Therefore, it is absolutely essential that moist heat
sterilization processes be properly designed, validated and controlled. PDA has developed three courses to keep you on track
when designing, validating or controlling a properly functioning moist heat sterilization process.
Steam Sterilizers: Getting it Right from the Beginning (July 21)

This is a comprehensive course to enable participants to understand sterilization processes using steam, design the right steam
sterilizer for particular applications, develop the load and cycle for those applications, perform qualification to demonstrate that the
design and development of the processes were robust, and provide ongoing process controls to maintain the qualified state.
Instructors:
Christopher J. Smalley, Associate Director, BioSterile Validation, Merck and Company, Inc.
Matt Hofacre, Director Application Project Management, Steris Corporation
Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Validation

and Ongoing Control (July 22)
This course will provide a foundational understanding of sterilization science (microbiology and thermal science) that will then be
applied in the selection of a cycle design approach, sterilization process development, process performance qualification and ongoing
process control. Important moist heat sterilization topics also covered by this course include: considerations in the use of steam and
water requirements for moist heat processes, fundamentals in the selection and use of biological indicators and chemical indicators,
selection of a sterilization process type based on product attributes, and design considerations for key and critical parameters.
Instructor:
Kevin D. Trupp, Principal Consultant Sterilization Technology and Compliance, Automated Systems Inc.
Steam in Place (July 23)

This course will enable participants to better understand how design and operational concepts can be applied to optimize steam
in place cycles (e.g., shorter and more lethal cycles) and also how to select the most applicable validation approaches. Training will
also include some exercises using risk assessment tools to determine if the system to be steamed should be considered sterilized
or sanitized, as that decision has a significant impact on the validation approaches that would be utilized for the initial and periodic
validations performed on the system. The primary objective of this course is to provide a better understanding of how to design,
operate and validate systems that are steamed in place.
Instructor:
Kevin D. Trupp, Principal Consultant Sterilization Technology and Compliance, Automated Systems Inc.
pda.org/moistheat
18
pda.org/courses
Risk-Based Qualification of Sterile Drug Product Manufacturing Systems

July 27 29, 2015

This course is designed to teach students the techniques for effective qualification and validation of sterile drug product
manufacturing systems. Taught at the PDA Training and Research Institute, this course makes extensive use of the Aseptic Processing
Suite to provide a combination of lecture and hands-on learning. Instructors will walk students through the planning, protocol
development, execution, and troubleshooting of the qualification of various drug product manufacturing systems, including critical
utilities, formulation/compounding, component parts sterilization, filling, and packaging. Lectures and case studies will provide
students with the regulatory expectations, industry trends, and best practices for qualification and validation of sterile drug product
manufacturing systems utilizing modern risk and science-based decision making approaches.
If you are involved with the planning, documentation, execution, or review of sterile drug product manufacturing system qualification
and validation for capital projects or on-going facility operation and remediation, this hands-on course will provide essential
knowledge and training in the approaches needed to successfully perform those functions.
Instructors:
Walter Henkels, Senior Consultant, Concordia ValSource
Marsha Stabler Hardiman, Senior Consultant, Concordia ValSource, LLC
pda.org/risk
Airflow Visualization Techniques and Practices

August 10 11, 2015

In this course, participants will discuss what components should be included in an airflow visualization study, such as intervention
assessments, movement effects, regulatory requirements and facility design elements. They will learn how the concept of first air
is related to product sterility and how unidirectional and turbulent airflow affects it. Participants will also learn how to incorporate
these elements into a contamination control program emphasizing good aseptic technique and cleanroom behavior. Participants
will get the opportunity to develop a protocol, conduct an airflow study and review their results. They will also learn how to visually
document their study in a way that allows the viewer to understand the process at hand.
Instructor:
David Matsuhiro, Principal, Cleanroom Compliance, Inc.
pda.org/air
pda.org/courses
19
Validation of Dry Heat Processes Used for Sterilization and Depyrogenation

August 12 14, 2015

This course is based on PDAs Technical Report 3, Validation of Dry Heat Processes Used for Depyrogenation and Sterilization. It focuses on
the microbiology and engineering qualification of dry heat depyrogenation processes and will provide a foundational understanding
of depyrogenation science. These concepts will then be applied in the design and verification of equipment, depyrogenation process
development, process performance qualification for new systems and ongoing maintenance of the validated process.
Instructors:
James Cooper,Consultant, Endotoxin Consulting Services
Wes Few,Consultant, ValSource, LLC
pda.org/depyro
GMP Week
August 17 19, 2015

Learn about GMPs for sterile and biotech products as well as how to apply quality systems to pharmaceutical GMPs.
GMPs for Manufacturers of Sterile and/or Biotechnology Products (August 17)

This course discusses the practical implementation of GMPs in facility and equipment design, process design and
operations. You will leave with an understanding of the microbiology of bacteria and their lethality, the regulatory expectations for
equipment and utility qualification and sterile process validation in order to assure that the products manufactured are proof-positive sterile.
Instructor:
Michael Anisfeld, President, Globepharm Consulting, Inc.
Application of a Quality Systems Approach to Pharmaceutical cGMPs (August 18 19)

This course will define the concepts behind the application of Quality Systems (QS) to drug operations and the specific elements as
discussed in the FDA guideline: Management Responsibilities, Resources, Manufacturing Operations and Evaluation Activities. It will also
describe the requirements in the ICH Q10 guideline and compare to the FDA document.
Specific discussion on each QS element from a risk-based approach will also be included so that the specific requirements can be
prioritized based on the highest impact to product quality.
Instructor:
Miguel Montalvo, President, Expert Validation Consulting, Inc.
pda.org/gmp
20
pda.org/courses
Fundamentals of an Environmental Monitoring Program

September 9 10, 2015

You will have the opportunity to work hands on with environmental monitoring equipment and media to develop a surface and
air environmental monitoring program for PDAs clean room. You will use the information presented in the lectures to determine
appropriate sampling sites and methods based on area classification, activities performed and surface type.
Instructors:
Dona Reber, SM (NRCM),Global Quality Operations, Microbiology and Aseptic Support,Pfizer
Marc Glogovsky, SM (NRCM),Global Business Manager SMA Division,Veltek Associates, Inc.
pda.org/enviro
NEW COURSE
Establishment of a Risk-Based Environmental Monitoring Program
September 11, 2015

This course will present information on the establishment of a risk-based environmental monitoring (EM) program. It will cover both
the establishment of new EM programs as well as reassessment of current EM programs to bring them into compliance with industry
standards. Routine EM Program requirements and EM program qualification requirements will be reviewed. Instruction will be given
on the use of risk tools for determination of microbial contamination sources in production environments and processes, and on the
use of EM risk assessment tools.
Instructor:
Marsha Stabler Hardiman, Senior Consultant, Concordia ValSource
pda.org/EMP
pda.org/courses
21
2015 Glass Quality, Visual Inspection and Foreign Material

Identification Week
September 14 18, 2015

PDA is offering three courses to help you develop a comprehensive program designed to identify and classify non-conformities in
your containers, visually inspect your final product and to analyze foreign material isolated during your inspections.
Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for
Pharmaceutical Manufacturing (September 14)
Through a series of lecture presentations accompanied by visual depictions of glass nonconformities, students will be provided with a
review of current best practices for identification and classification of visual nonconformities in glass containers. The course will also present
criteria such as the development and use of appropriate sampling plans for incoming inspection of glass containers and the appropriate
application of Acceptable Quality Limits for accept/reject decisions. The importance of the partnership between glass manufacturers and
the pharmaceutical company using the glass containers in establishing glass container quality specifications will be emphasized.
Instructor:
Nicholas R. Debello, Principal,DeBello & Associates LLC
An Introduction to Visual Inspection (September 15 16)

Covering the fundamentals of visual inspection and their application to injectable products, this course will
be a combination of lecture/discussion and hands-on laboratory exercises used to develop and practice practical inspection skills.
The skills developed through this course may be applied to both manual human inspection and automated machine inspection.
Instructors:
John Shabushnig, PhD, Independent Consultant, Insight Pharma Consulting, Inc.
Ronald Leversee, QA External Operations, Perrigo Company
Matt Ostrowski, Injectable Inspection Team Leader,Pfizer, Inc.
NEW COURSE
Foreign Particulate Examination, Isolation and Analysis(September 17 18)
Instructors will discuss what foreign particulates are and why it is important to identify their composition and potential sources. Three
analytical techniques will be covered polarized light microscopy, infrared spectroscopy and scanning electron microscopy. Students will
get hands-on training in sample preparation, sample analysis and sample interpretation. After the course, students will have developed
particle isolation and particle handing skills and be able to explain the analytical methods used in identifying particulate matter.
Instructors:
Rich Brown,Executive Director, MVA Scientific Consultants
Mary Miller,Executive Director, MVA Scientific Consultants
Ming Zhou,Business Development, MVA Scientific Consultants
pda.org/glassqual
22
pda.org/courses
Utilization of Statistical Methods for Production Monitoring

September 22, 2015

This course will provide guidance to help attendees identify and use statistical process monitoring methods. The appropriate use of
statistical methods will be conveyed at a level and in a way that will be easily understood. The various methods will be described,
typical applications will be identified and pros and cons of each method will be examined. Examples of each method will be provided
to illustrate how each can be used in a real-world setting.
Instructor:
Jason Orloff, Chemical Engineer & Statistician, PharmStat
pda.org/statistics
pda.org/courses
23
2015 PDA Regulatory Conference Course Series

October 1 2, 2015
Renaissance Washington DC Hotel | Washington, DC

What do you get when you cross in-depth training, six experts and two days? PDAs Regulatory Conference Course Series!
In two days, you and your colleagues will learn more about risk based product development, quality metrics, root cause
investigations and much more!
Risk-Based Product Development Basics for Combination Products: Harmonizing Design Controls and
Quality-by-Design in Product Development and Market Authorization Documents (October 1)
This course provides an overview of the challenges encountered in developing a combination product. It focuses on drug-device or
biologic-device products with an emphasis on how the controlled development process (design control and QbD) and the associated
documentation of product and process development can support good regulatory submissions. The objective of the course is to
introduce and harmonize the basic requirements of FDAs design controls (21 CFR 820.30) with Quality-by-Design expectations.
Instructor:
Carol DeSain, President, The Tamarack Group North Shore, LLC
Quality Metrics: Performance Indicators (October 1 2)

This course will help participants select the appropriate quality metrics, determine how best to collect the data and how to use the
data to improve the Quality System. The types of processes to be discussed include the production process; supporting processes,
such as change control, training, and validation; supplier processes and materials management.
Instructor:
Robert G. Kieffer, PhD, President, RGK Consulting
Root Cause Investigation for CAPA (October 1 2)

This course will engage participants in learning a systematic, science-based methodology to identify the cause(s) for a decline in the
performance of a machine, piece of equipment, product (tangible or intangible), or work process (physical or virtual). Once identified,
the methodology determines appropriate corrective actions to restore performance, preventive actions to assure similar issues do not
occur, and a control plan to assure the original problem does not return.
Instructor:
Tom Weaver, President, Weaver Consulting, LLC
24
pda.org/courses
Process Validation and Verification: A Lifecycle Approach (October 1 2)

This course is designed to explain and facilitate the implementation of Process Validation (PV) and Continued Process Verification (CPV)
from a practical perspective. The three stages of process validation activities will be addressed, from the design stage through commercial
production. Participants will gain the knowledge they need to ensure that process validation strategies and approaches are consistent
with current regulatory and quality system thinking. Attendees will be able to apply these concepts when they return to their jobs.
Instructors:
Scott Bozzone, Sr. Manager, Quality Systems and Compliance- Validation, Pfizer, Inc.
Wendy Lambert, Divisional Validation Leader, Global MS&T, Novartis Pharma AG
CMC Regulatory Requirements in Drug Applications (October 2)

This course provides a basic understanding of CMC requirements in drug applications. It will help prepare
those in regulatory affairs to better address the key points required in the CMC sections of drug applications. Topics to be covered
include CMC in Investigational New Drug (INDs) applications, New Drug Applications (NDAs), Abbreviated New Drug Applications
(ANDAs), drug master files, and post-approval change supplements. Compliance to Current Good Manufacturing Practice (cGMP)
will also be briefly discussed.
Instructor:
Zi-Qiang Gu, PhD, Pharmaceutical Consultant, Former FDA CMC reviewer and GMP Compliance Officer
pda.org/pdacourses
pda.org/courses
25
Filtration Week
October 12 16, 2015

Whether you are new to the industry or a veteran in the biopharmaceutical industry, you can enhance your knowledge in
the use of filters during PDAs Filtration Week.
Filters and Filtration in the Biopharmaceutical Industry: Basics Course (October 12 13)
This highly interactive training course is intended to provide a fundamental understanding of biopharmaceutical filtrations and filters
that will enable the participants to concentrate on the use of filters for the demanding and critical operations for the manufacture of
aseptic products. Practical applications and experiences of filter usage, economics and performance of system designs, integrity test
methods, and process validation of filter devices will be the focus.
Instructors:
Maik Jornitz, CEO, G-Con
Wayne Garafola, Field Application Specialist Biotechnology Division, Sartorius Stedim Biotech
Filters and Filtration in the Biopharmaceutical Industry: Advanced Course (October 14 16)
This advanced course is a three-day laboratory course comprising 30% lecture and 70% hands-on training. The combination of
theoretical and practical work makes this course a highly valuable learning experience for end-users, trainers and regulators.
Coursework includes measurement of unspecific adsorption on different filter membrane polymers and the implication of such
adsorption for any filtration process. Since filter sizing and optimal filter combination choice is essential for biopharmaceutical
filtration processes, the course also includes filterability trials, sizing and scaling. Interactivegroup work will include determining
optimal filter combination for particular case studies detailed by the faculty.
Instructors:
Maik Jornitz, CEO, G-Con
Wayne Garafola, Field Application Specialist Biotechnology Division, Sartorius Stedim Biotech
pda.org/filtration
26
pda.org/courses
Validation of Moist Heat Sterilization Processes

October 21 23, 2015

This three-day course includes lecture and hands-on training in the science of sterilization (microbiology and thermal science) with a
fully functional steam autoclave and thermal validation equipment. Bring your challenges to the course and brainstorm with the class
and Instructor while running actual loads. The foundational understanding you gain will then be applied in the selection of a cycle
design approach, sterilization process development, process performance qualification and ongoing process control.
Instructor:
Deborah Drew, President and CEO, Drew Quality Group, Inc.
pda.org/sterilization
PDA 10th Annual Global Conference on Pharmaceutical Microbiology Course Series

October 22-23, 2015

The learning doesnt have to end with the 10th Annual PDA Conference on Pharmaceutical Microbiology. On October 22-23,
PDA will be hosting three courses to complement the knowledge you have acquired at the conference!
Investigating Microbial Data

Deviations (October 22)
This course will provide practical insights into both the regulatory
and scientific elements that must be taken into consideration
when investigating microbiological data deviations. Participants
will come away with an understanding not only of what the
considerations are, but also a practical approach to designing
and conducting investigations into microbiological test data that
appears inconsistent with expectations and trends.
Instructor:
Jeanne Moldenhauer, Excellent Pharma Consulting
Evaluation, Validation and

Implementation of Alternative and
Rapid Microbiological Testing Methods (October 22 23)
This course is designed to provide attendees with an overview
of the revised Technical Report No. 33, Evaluation, Validation
and Implementation of Alternative and Rapid Microbiological
Testing Methods, and how the report can be used as the basis
for the validation and implementation of alternative and rapid
microbiological methods (RMMs). Attendees will be immersed in
discussions that will provide a meaningful and understandable

roadmap for how to evaluate alternative and RMMs and employ
them in their own laboratory and manufacturing areas.
Instructor:
Michael J. Miller, PhD, President, Microbiology Consultants, LLC
Regulatory Aspects of Microbiology in a Non-Sterile

Environment (October 23)
Non-sterile microbiology offers many challenging regulatory
issues often not considered in aseptic manufacturing because
the rules are minimal when compared to those governing
aseptic manufacturing. This course discusses various regulations
and how they impact non-sterile manufacturing. Topics include
the setting of specifications, development of processes, holding
times, preservation issues, cleaning, sanitization and the
requirements for the testing for recovered microorganisms.
Instructor:
Barry Friedman, PhD, Consultant, Barry A. Friedman, PhD, LLC
pda.org/microcourses
pda.org/courses
27
An Introduction to Visual Inspection

October 28 29, 2015

This course covers the fundamentals of visual inspection and their application to injectable products. Through a combination of
lecture/discussion and hands-on laboratory exercises, participants will develop and practice practical inspection skills that can then
be applied to both manual human inspection and automated machine inspection.
Upon completion of this course you will be able to:

Identify applicable international regulatory and compendial requirements for visual inspection
Apply the critical parameters which must be controlled for reproducible inspection results
Use appropriate statistical tools to assess and compare inspection methods
Develop consistent validation strategies for visual inspection processes and equipment
Instructors:
John Shabushnig, PhD, Independent Consultant, Insight Pharma Consulting, Inc.
Ronald Leversee,QA External Operations, Perrigo Company
Matt Ostrowski,Injectable Inspection Team Leader, Pfizer, Inc.
pda.org/visualcourse
28
pda.org/courses
Quality Risk Management Week

November 9 13, 2015

If improving quality and reducing risk are important to you, then you simply cannot afford to miss this week!
Implementation of Quality Risk Management for Commercial Pharmaceutical and Biotechnology

Manufacturing Operations (November 9 10)
This course will provide detailed guidance for application and implementation of quality risk management principles throughout
the product lifecycle, with emphasis on quality risk management application during commercial manufacturing, and integrating
quality risk management into the Pharmaceutical Quality System. It will build on the content and principles of ICH Q9, Quality Risk
Management, and provide case study examples of the application of quality risk management for different types of manufacturing
operations such as biotech API manufacturing, drug product manufacturing, packaging and labeling.
Instructors:
Jeff Hartman, Director, Validation Quality Assurance, Merck and Company, Inc
Emma Ramnarine, Senior Director, Head Global Biologics QC, Genentech
Implementation of Quality Risk Management: Case Studies in the Manufacturing of Biotechnological Bulk
Drug Substances (November 11 12)
This course will consist of lectures and workshops designed to help participants identify risks in bioprocesses.Participants will work in
small groups on open-ended scenarios to identify risk groups and judge their magnitudes and potential impacts. The workshops will
include training in particular risk tools that are introduced throughout the course. Participants will gain increased awareness of risks
and strategies for risk reduction in bioprocess development and manufacturing.
Instructor:
Scott Rudge, PhD, COO, RMC Pharmaceutical Solutions, Inc.
Implementation of Quality Risk Management: Case Studies in the Manufacturing

of Pharmaceutical Drug Products (November 11)
This interactive course will provide practical examples of how to use and apply quality risk management in drug manufacturing
operations, including the benefits and challenges. Lecture and breakout sessions will provide attendees with practical examples of
how to use quality risk management across the product life cycle to improve product quality and compliance. Specific case studies
from drug manufacturing will be presented.
Instructor:
Ghada Haddad, Director, Engineering, Sterile & Validation CoE, Merck and Company, Inc.
pda.org/riskmanage
pda.org/courses
29
The Quality Culture and its Measurement

November 11, 2015

Learn to evaluate your company culture and improve it with this course!
This course will provide an opportunity to discuss the components of a quality culture, how to measure those components and
strategies for enacting change through a combination of lecture and small group exercises.
pda.org/metricscourse
2015 PDA Vaccines Course Series

December 3 4, 2015

The 2015 PDA Vaccines Course Series is made up of two courses that help you and your colleagues learn the current
challenges in Vaccines and techniques for modern manufacturing and trend monitoring!
Current Challenges in Vaccines (December 3)

You will learn the complexities and unique challenges of the vaccine field when you take this course, and will be able to provide a
basis for assessing and proposing resolutions to manufacturing and quality issues. This course will explore the variety of currently
licensed vaccines to understand todays regulatory, quality and manufacturing challenges by reviewing some historical precedents
to demonstrate how the unique vaccine regulatory landscape was established. Case studies will be presented to underline topics of
particular interest to the field today. The course format will be lecture and discussion.
Instructor:
Kirsten L. Vadheim, PhD, Principal Consultant, BioCompliance Consulting, Inc
Modern Manufacturing and Trend Monitoring Techniques for Vaccines (December 4)

This course will provide a brief review of effective methods for vaccine manufacturing processes and will also discuss how to
maximize controls to meet and exceed current international regulatory expectations. Case studies will be presented to provide
practical examples of how to control scale-up, design for quality, operate effective GMP change controls for processes and how to
effectively validate systems, facilities and processes. Participants will come away from this course with a better understanding of
the speed bumps, road-blocks, common mistakes, complexities and unique challenges of the vaccine manufacturing and quality
assurance environments. This course will provide the participant with a basis for better controlling and anticipating emerging
manufacturing and quality issues.
Instructor:
Anthony M. Luttrell, Principal, Luttrell Consulting Group, LLC
pda.org/vaccinescourses
30
pda.org/courses
PDA Education Where Excellence Begins
Turn your knowledge into

action in one of the labs
Microbiology
Biochemistry
Cleanroom
Learn from industry

experts who
Developed it
Invented It
Tested It
Know It
60 classroom and lab courses

designed to meet the challenges
you face
Aseptic Processing
Biotechnology
Environmental Monitoring
Filtration
Validation
Quality Control
Regulatory Affairs
Begin Your Excellent Experience Today

with PDA Education.
pda.org/courses
Quality Systems for Aseptic Processing

November 16 20, 2015

This five-day comprehensive training program will give you and your personnel the tools necessary to optimize your Quality Systems
associated with Aseptic Processing. Taught by leading industry experts with more than 100 years of combined experience, this
course combines the three modes of learning; Visual, Auditory and Kinesthetic, with almost 50% laboratory interaction to maximize
information retention. Major topics include; Risk Management, Sterility by Design, troubleshooting and solving sterile filtration issues,
investigations and CAPA, and how to effectively implement change within a structured regulated environment.
Instructors:
David Matsuhiro, President, Cleanroom Compliance, Inc.
Numerous additional industry experts round out the faculty to give you a complete educational experience.
pda.org/qualityAP
Fundamentals of Aseptic Processing

December 7 11, 2015

This 5-day laboratory course will provide you with an understanding of the fundamental principles governing aseptic processing.
Systems associated with aseptic processing and how they work together to help ensure a sterile product will be covered.
Upon completion of this course, you will be able to:

Outline the process steps involved in producing aseptically filled products

Describe how different aspects of aseptic processing are interrelated
Identify microorganisms of specific concern in controlled environments and their origins
Discuss your specific role in aseptic processing and how you fit in
Explain the process steps most commonly described as risky, and how you can manage those risks
Instructors:
Carol Lampe, Trainer and Consultant
Brent Watkins, Southeast Sales Manager, Veltek Associates Inc.
pda.org/FAP2
32
pda.org/courses
DATES
COURSE NAME
LOCATION
7/21 7/23
Moist Heat Sterilization Week | pda.org/moistheat
7/21
Steam Sterilizers: Getting it Right from the Beginning
7/22
Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Validation and Ongoing Control
7/23
Steam in Place
TYPE
Bethesda, MD
Lecture
7/27 7/29
Risk-Based Qualification of Sterile Drug Product Manufacturing Systems | pda.org/risk
Bethesda, MD
Lab
8/3 8/7
8/24 8/28
Bethesda, MD
Lab
SOLD OUT
8/10 8/11
Airflow Visualization Techniques and Practices New Course | pda.org/air
Bethesda, MD
Lab
8/12 8/14
Validation of Dry Heat Processes Used for Sterilization and Depyrogenation | pda.org/depyro Bethesda, MD
Lab
8/17 8/19
GMP Week | pda.org/GMP
8/17
GMPs for Manufacturers of Sterile and/or Biotechnology Products
8/18 8/19
Application of a Quality Systems Approach to Pharmaceutical cGMPs
Bethesda, MD
Lecture
Bethesda, MD
Lab
Establishment of a Risk-Based Environmental Monitoring Program New Course |

pda.org/EMP
Bethesda, MD
Lecture
9/14 9/18
Glass Quality, Visual Inspection and Foreign Material Identification Week | pda.org/glassqual
Bethesda, MD
Lecture/Lab
9/14
Identification and Classification of Nonconformities in Molded and Tubular Glass Containers

for Pharmaceutical Manufacturing
Utilization of Statistical Methods for Production Monitoring | pda.org/statistics
Bethesda, MD
Lecture
10/1 10/2
2015 PDA Regulatory Conference Course Series | pda.org/pdacourses
Washington, DC
Lecture
10/1
Risk-Based Product Development Basics for Combination Products: Harmonizing Design Controls and Qualityby-Design in Product Development and Market Authorization Documents
10/1 10/2
Quality Metrics: Performance Indicators
10/1 10/2
Root Cause Investigation for CAPA
10/1 10/2
Process Validation and Verification: A Lifecycle Approach
10/2
CMC Regulatory Requirements in Drug Applications
Bethesda, MD
Lab
Bethesda, MD
Lecture/Lab
Bethesda, MD
Lab
Bethesda, MD
Lecture
Bethesda, MD
Lab
Bethesda, MD
Lecture
Bethesda, MD
Lecture
Bethesda, MD
Lab
Bethesda, MD
Lecture
Bethesda, MD
Lab
9/9 9/10
9/11
9/15 9/16
9/17 9/18
9/22
10/5 10/9
11/2 11/6
Fundamentals of an Environmental Monitoring Program | pda.org/enviro
An Introduction to Visual Inspection

Foreign Particulate Examination, Isolation and Analysis
10/12 10/16
Filtration Week | pda.org/filtration
10/12 10/13
Filters and Filtration in the Biopharmaceutical Industry: Basics Course
10/14 10/16
10/21 10/23
NEW SESSION ADDED
Filters and Filtration in the Biopharmaceutical Industry: Advanced Course
Validation of Moist Heat Sterilization Processes | pda.org/sterilization
10/22 10/23
PDA 10th Annual Global Conference on Pharmaceutical Microbiology Course Series |

pda.org/microcourses
10/22
Investigating Microbial Data Deviations
10/22 10/23
Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Testing Methods
10/23
Regulatory Aspects of Microbiology in a Non-Sterile Environment
10/28 10/29
An Introduction to Visual Inspection | pda.org/visualcourse

Immediately following the 2015 PDA Visual Inspection Forum
11/9 11/12
Quality Risk Management Week | pda.org/riskmanage
11/9 11/10
Implementation of Quality Risk Management for Commercial Pharmaceutical and Biotechnology

Manufacturing Operations
11/11
Implementation of Quality Risk Management: Case Studies in the Manufacturing of Pharmaceutical Drug Products
11/11 11/12
Implementation of Quality Risk Management: Case Studies in the Manufacturing of Biotechnological Bulk
Drug Substances
11/11
11/16 11/20
The Quality Culture and its Measurement | pda.org/metricscourse

Immediately following the 2015 PDA Pharmaceutical Quality Metrics Conference
Quality Systems for Aseptic Processing | pda.org/qualityAP
12/3 12/4
2015 PDA Vaccines Course Series | pda.org/vaccinescourses
12/3
Current Challenges in Vaccines
12/4
Modern Manufacturing and Trend Monitoring Techniques for Vaccines
12/7 12/11
Fundamentals of Aseptic Processing | pda.org/FAP2
REGISTRATION INFORMATION: You can register for PDA courses one of three ways: online, fax or mail. To register online, please visit pda.org/courses,
find your course of choice and click the Register Now button. You may also submit a registration form along with payment information by fax or postal
mail. Please visit pda.org/triregistration for more information. If you have any questions, please call 301-656-5900 ext. 115.
Current as of 5/1/15
Parenteral Drug Association U.S. Education Courses

Where Excellence Begins
PDAs U.S. Education Courses cover a broad range of subject areas reflecting PDAs core competencies
aseptic processing, biotechnology, environmental monitoring, filtration, microbiology, quality/regulatory affairs,
and validation, as well as specialized areas such as lyophilization, pre-filled syringes and visual inspection.
Consistent with PDAs strategic plan, the courses are updated regularly and new offerings are added to reflect
current and upcoming technical, scientific and regulatory topics within those core competencies.
pda.org/courses

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2015 PDA U.S. Education Courses

Laboratory and Classroom Training for Pharmaceutical

2015 PDA U.S. Education Courses

Aseptic Processing Training Program, Session 1 | pda.org/2015aseptic1

Fundamentals of Aseptic Processing | pda.org/FAP1

2015 PDA Annual Meeting Course Series | pdannualmeeting.org/courses

Technical and Regulatory Challenges of Combination Drug Delivery Products

The Quality Culture and Its Measurement New Course

Sterile Pharmaceutical Dosage Forms

Developing a Robust Supplier Management Process

Aseptic Processing Training Program, Session 2 | pda.org/2015aseptic2

Train the Trainer Week | pda.org/trainer

Qualifying Your SMEs as Trainers

Learning, Knowledge Management and Impact: Moving from Theory to Practice

Designing/Presenting GXP Training Programs to Meet FDA Requirements

Lyophilization Week | pda.org/lyo

Validation of Biotechnology-related Cleaning Processes | pda.org/biotechclean

Recommended Practices for Manual Aseptic Processes | pda.org/MAP

Aseptic Processing Training Program, Session 3 | pda.org/2015aseptic3

2015 PDA Pharmaceutical Packaging Course Series | pda.org/packagingcourses

Selection and Utilization of Glass Containers in Pharmaceutical Packaging

Technical Development of Prefilled Syringes, Autoinjectors and Injection Pens | pda.org/techdevelop

Management of Aseptic Processing | pda.org/apmanagement

Process Simulation Testing for Aseptically Filled Products | pda.org/simulation

Fundamentals of Cleaning and Disinfectant Programs for Aseptic Manufacturing

2015 PDA Aseptic Processing Sterilization Course Series | pda.org/sterilizationcourses

Process Simulation Testing for Aseptically Filled Products

Recommended Practices for Manual Aseptic Processes

2015 PDA Single Use Systems Workshop Course Series | pda.org/suscourses

Assessing Packaging and Processing Extractables/Leachables

Single Use Systems for the Manufacturing of Parenteral Products

Application of Phase-Appropriate GMP to the Development of Protein Bulk Drug Substances |

A Former Investigators Perspective on Conducting Effective Deviation Investigations, Root

PDA U.S. Education Courses | M A R C H D E C E M B E R 2 0 1 5

Fundamentals of Aseptic Processing

PDA Training and Research Institute | Bethesda, Maryland

Outline the process steps involved in producing aseptically filled products

Connecting People, Science and Regulation

2015 PDA Annual Meeting Course Series

Red Rock Casino, Resort and Spa | Las Vegas, Nevada

Technical and Regulatory Challenges of Drug Delivery Combination Products

The Quality Culture and its Measurement (March 19)

PDA U.S. Education Courses | M A R C H D E C E M B E R 2 0 1 5

Sterile Pharmaceutical Dosage Forms: Basic Principles (March 19 20)

Developing a Robust Supplier Management Process (March 20)

Connecting People, Science and Regulation

2015 Aseptic Processing Training Program

Session 1: January 26 30 and February 23 27, 2015 SOLD OUT

By popular demand, a new fifth session of

PDA Training and Research Institute | Bethesda, Maryland

PDA U.S. Education Courses | M A R C H D E C E M B E R 2 0 1 5

Train the Trainer Week

PDA Training and Research Institute | Bethesda, Maryland

Qualifying Your SMEs as Trainers (April 20)

Designing/Presenting GXP Training Programs to Meet FDA Requirements (April 23)

Connecting People, Science and Regulation

Validation of Biotechnology-related Cleaning Processes

PDA Training and Research Institute | Bethesda, Maryland

PDA U.S. Education Courses | M A R C H D E C E M B E R 2 0 1 5

PDA Training and Research Institute | Bethesda, Maryland

Fundamentals of Lyophilization (May 4 5)

Validation of Lyophilization (May 6 7)

Connecting People, Science and Regulation