Pharma Cold Chain Logistics

FREE!
Schiphol
Site Visit &
Workshop
Pharma by
Road*
The Parenteral Drug Association presents:
2016 PDA Europe
Pharmaceutical Cold &

Supply Chain Logistics
10 October
Schiphol Airport Site Visit
On-Site Workshop Pharma by Road
13 October
Good Qualification Practice
13-14 October
Secure Cold Chain Practices
14 October
Supply Chain Strategies for API
and Drug Product
pda.org/EU/ColdChain2016
11-12 October 2016
Register by
11 Sept 2016
and SAVE!
Novotel Amsterdam Schiphol Airport
Amsterdam | The Netherlands
Supporter
Silver Sponsor
Gold Sponsors
Platinum Sponsor
SCHIPHOL AIRPORT SITE VISIT

Monday, 10 October 2016
12:15 18:30
PDA Europe Schiphol Airport Site Visit

Overview
In the second edition of the PDA Europe Schiphol Airport Site Visit, PDA is proud to offer insights into the
facilities of leading partners in ground handling, freight forwarding, supplying of active air containers and
warehousing. Participants can also choose to join the onsite workshop Pharma by Road to discuss the
minimal requirements for temperature-controlled trucking in Europe.
PDA Europe is proud and grateful to Schiphol Amsterdam, DHL Global Forwarding, Envirotainer,
and Panalpina & Worldwide Flight Services for their generous support and cooperation!
Please be warmly invited to join one of the following two tours:
S CH E DU LE
12:15
Joint Departure: Bus Transfer provided by Envirotainer

Conference Hotel to Schiphol Airport Offices
Tour A:
Workshop Pharma by Road + Site Visit Panalpina & Worldwide Flight Services
12:30
Lunch provided by Schiphol Airport
13:00
Workshop Pharma by Road (please see this brochure for details)
15:00
Bus Transfer and Site Visit of Panalpina & WFS
16:45
Bus Transfer returning to Schiphol Airport Offices
Tour B:
Site Visits to DHL Life Science Competence Center + Envirotainer
12:30
Lunch provided by DHL Global Forwarding
13:00
Presentation & Site Visit DHL Life Science Competence Center
15:00
Bus Transfer and Site Visit of Envirotainer
16:45
Bus Transfer returning to Schiphol Airport Offices
17:00
Welcome Reception provided by Schiphol Airport
18:30
Bus Transfer returning to Conference Hotel
SCHIPHOL AIRPORT SITE VISIT
Schiphol Airport Site Visit Partners

New Panalpina GDP licensed Centre of Excellence at Amsterdam Airport
5 years after Panalpina Amsterdam received the GDP wholesalers license from the Ministry of Health,
Panalpina Amsterdam has now decided to make the next step in pharma handling by relocating the Pharma activities to a dedicated, GDP licensed warehouse: Freight Station 6e. The new location has direct access to the tarmac, which makes it stand out both
in terms of speed and in terms of maintaining cargo integrity for temperature sensitive goods. The facility, physically handled by
WFS, consists of 2.000 sqm under active temperature control, maintaining the temperature between 15-25 degrees Celsius. The 2-8 degrees
Celsius cool room within the facility consists of 2 compartments, totaling 150 sqm. This GDP wholesalers licensed facility allows Panalpina to
offer companies in the pharmaceutical industry the entire spectrum
of logistics activities that they demand, such as Air Freight handling,
Ocean Freight handling, Truck handling, Storage (longer than 48 hours),
Active/Passive packaging of pharmaceutical goods, to name but a few.
Panalpina is looking forward to your visit to show our capabilities.
DHL Life Science Competence Center at Amsterdam-Schiphol
DHL Global Forwarding, the air and ocean freight specialist of Deutsche Post DHL Group, recently opened
a new logistics center for life science and healthcare products at Amsterdam-Schiphol. The new so-called Life Science Competence Center serves as a hub for the transport, transport preparation, temporary storage, and transport follow-up of active and
passive temperature-controlled pharmaceutical and medicinal products. Come and visit the 1,000 square meters facility which consists
of two areas: one is dedicated to pharmaceutical products that must
be stored at constant temperatures between two and eight degrees
Celsius, while the second one allocated to a controlled temperature
range of between 15 to 25 degrees Celsius. Together with the special
temperature-controlled loading area, the center meets the high quality levels expected of the life sciences industry.
The Envirotainer EMEA Service Competence Center, located in Amsterdam, is approximately
1,600 square meters consisting of two buildings and a large outside storage lot. The front building
holds the workstations for container repairs, the storage for materials and the offices. The rear building and the outside lot are
used for quarantine and storage of equipment. Inspection Services Inspection and
testing containers is completed upon arrival at the facility to determine airworthiness.
Inspection and testing includes, but not limited to; physical inspection of the container, inspection of the life-limit parts and performing functional testing of the container.
Repair Services Repair and maintenance of the containers is done in accordance
with Envirotainer: Maintenance Organisation Exposition (MOE) Component Maintenance Manual (CMM) and Service Information letters We have a team of 10 employees working in Amsterdam. In addition to the inspection and testing of containers our
team also repairs containers at a rate of 200-300 per month. We also have our own
truck and the team can quickly respond to urgent deliveries.
WORKSHOP
Monday, 10 October 2016 | Schiphol Airport Offices
13:00 15:00
Pharma by Road
Overview
In a special interactive roundtable format onsite, you will discuss and exchange with experts on the
minimal requirements for trucking in Europe. With a lack of existing standards and little alignment in
services and modalities to use, pharma companies are often left alone in making these critical decisions. This workshop will facilitate exchange among representatives of some of the leading service
providers and pharma companies, promising lively discussions and ready-to-use business advice.
This workshop will cover temperature controlled transport of (bio-) pharmaceutical products at 2-8C
and 15-25C. In this interactive workshop, all participants get the opportunity to discuss and share best
practices in order to answer the following questions:
Which regulatory requirements apply to temperature controlled (TC) road vehicles?
What types of TC road vehicles are present in the market place?
What are the critical design parameters for TC road vehicle equipment, qualification and
operational handling?
Which requirements apply to qualify a TC road vehicle and/or family of TC road vehicles and
operational handling?
What are the minimal pharma requirements towards TC road vehicles?
Workshop Leaders:
Erik van Asselt, PhD, MSD
Rafik Bishara, PhD, Technical Advisor
Are your pharmaceuticals

on time, in the right condition,
and in the right location?
Now its easy to know with the industrys only validated

real-time temperature datalogger.
Sensitechs TempTale GEO and ColdStream Tracks enable users to monitor condition geo-location and light in real
time to enable critical pharmaceutical logistics decision making.
Key features and benefits include:
Improved logistics and supply chain performance to increase
chain-of-custody insight through real-time visibility.
Reduced risk through timely and active intervention in order to address
correctable temperature excursions and shipment delays.
Simplified temperature-sensitive supply chain monitoring with a
comprehensive solution that includes data collection, analysis,
and expert support.
Facilitated view of supply chain through secure data management in the
ColdStream validated hosted environment, with real-time access through
a self-service user interface.
Sensitech helps you to protect product integrity every step of the way.
www.sensitech.com
2016. Sensitech Inc. All rights reserved.
Amsterdam Bangalore Boston Hong Kong Melbourne Santiago Shanghai
Sensitech EMEA Lireweg 42-52 P.O. Box 59 2150 AB Nieuw-Vennep The Netherlands
www.sensitech.com info@sensitech.eu Tel: +31 (0)252 211 108 Fax: +31 (0)252 231 032
LETTER FROM THE CO-CHAIRS

Dear Colleagues,
After the tremendous success of the previous PDA Europe Pharmaceutical Cold & Supply Chain Logistics
Conference in Amsterdam last year, we are proud to announce that this years conference will again be hosted in
collaboration with Amsterdam Airport Schiphol in Amsterdam, The Netherlands, 11-12 October!
Contributions will come from all supply chain partners such as manufacturers, wholesalers, suppliers, logistic service
providers. Regulators and industry representatives from WHO, Pfizer, MSD, GSK, TEVA, EFPIA, EMVO, Thermo King and
other groups and companies will provide presentations on GDP compliance, transport risk mitigation, optimization
in ocean freight, developments in airfreight, supply chain security and temperature control. The conference promises to provide a week of knowledge acquisition, technical debates and continued learning that you will benefit from
enormously. As usual, we will have roundtable discussions, network events and a vendor exhibition as well.
The two-day conference will be preceded by the second edition of the PDA Europe Schiphol Site Visits on Monday,
10 October, offered with the generous support and commitment of various collaborating partners. During the Site
Visit, participants can also choose to join an onsite workshop on Pharma by Road. In a special interactive roundtable format, we will discuss and exchange expert advice on the minimal requirements for trucking in Europe. With a
lack of existing standards and little alignment in services and modalities to use, pharma companies are often alone in
making these critical decisions. Our workshop will facilitate exchange among representatives of some of the leading
service providers and pharma companies, promising lively discussions and ready-to-use business advice.
The weeks agenda is made complete by PDA Education & Training providing a one-day training course on
Good Qualification Practice of Pharma Storage and Transportation Equipment on 13 October, and a two-day
workshop on Secure Cold Chain Practices on 13 & 14 October.
A one-day training course on Outsourcing from API to Drug Product on 14 October will round off this fantastic week
of events scheduled for this fall!
Please review all agendas included in the program brochure and sign up early to save!
Dont miss this opportunity to learn about and exchange on the latest advancements in Supply & Cold Chain Logistics
in Amsterdam this October!
Sincerely
The Co-Chairs
Erik van Asselt
Rafik Bishara
PROGRAM PL ANNING COMMITTEE

1 Erik van Asselt, MSD, Conference Co-Chair
2 Rafik Bishara, Technical Advisor, Conference Co-Chair
3 Henry Ames, Sensitech
4 Monica Derecque-Pois, GIRP

5 Nina Heinz, DHL
6 Zvonimir Majic, TEVA
7 Bart Pouwels, Schiphol Airport
8 Georg Roessling, PDA Europe
INFORMATION
WHO SHOULD ATTEND
Pharmaceutical/Biopharmaceutical | Development | Packaging | Manufacturing | Transportation and Logistics | Airlines
| Cold Storage | Wholesale/Retail Pharmacy | Suppliers of
Cold Chain Solutions | Cold Supply Chain | Logistic Service
Providers/Carriers | Warehouse | Quality Release | Quality
Assurance | Qualified Person | Security Personnel
VENUE
Novotel Amsterdam Schiphol Airport
Taurusavenue 12
2132 LS Hoofddorp
Netherlands
Tel: +31 20 721 9180
http://bit.ly/245KiqB
ORGANIZER
PDA Europe gGmbH
Am Borsigturm 60
13507 Berlin, Germany
Tel: +49 30 4365508-0
Fax: +49 30 4365508-66
CO N F E R E N C E R EG I S T R AT I O N H O U R S
Monday, 10 October: 8:00 16:00h
Tuesday, 11 October: 7:30 17:30h
CO U R S E R EG I S T R AT I O N H O U R S
Thursday, 13 October: 7:30 17:30h
Friday, 14 October: 7:30 10:00h
Housing at the selected hotel will be in high demand, so

we strongly recommend making your reservations early.
D I R EC T I O N S
NOVOTEL AMSTERDAM
SCHIPHOL AIRPORT
Google
For directions click
on the picture, scan
the QR-code or go to
https://goo.gl/udPtKw
T O E X H I B I T:
Exhibition and Sponsorship Opportunities are available.
PDA meetings and conferences are a great opportunity for
your company to gain on-site exposure in front of highly-qualified, upper-level professionals in the pharmaceutical and biopharmaceutical industry. Exhibit at PDA events
and let your companys products or services become a
valuable tool or resource for our attendees.
S PEC I A L R E QU I R E M E N T S
If you require special accommodations to fully participate, please attach a written description of your
needs with your registration form. Specific questions can
be directed to registration-europe@pda.org.
CO N TAC T I N FO R M AT I O N
Conference Inquiries
Melanie Decker
Director Events & Exhibitions
decker@pda.org
Conference Program Inquiries
Sylvia Becker
Manager Programs & Events
becker@pda.org
Registration Customer Care
Tel: +49 30 4365508-10
registration-europe@pda.org
Education Program Inquiries
Elke von Laufenberg
Manager Training & Education
laufenberg@pda.org
Exhibition/Sponsorship Inquiries
Creixell Espilla-Gilart
Manager Exhibition & Sponsorship
espilla@pda.org
Special offer: Discounted travel with Lufthansa Group Airlines

Lufthansa Group Partner Airlines offer a comprehensive global
route network linking major cities around the world. We offer special prices and conditions to participants, visitors, exhibitors, invited guests as well as employees of the Contracting partner and
their travel companions. To make a reservation, please click on
www.lufthansa.com/event-booking_en and enter the access code
DEZZYPE in the "Access to Your Special Lufthansa Offer" area. This
will open an online booking platform that will automatically calculate the discount offered or provide you with an even better offer if
another promotional fare is available.
NOTE: Pop-ups must be enabled otherwise the booking platform
window will not open.
These promotional fares are also available through your IATA / ARC
travel agent. Travel agents can obtain ticketing instructions by sending an email to lufthansa.mobility@dlh.de and providing the
access code as a reference.
CONFERENCE AGENDA
28 September 2016
Tuesday, 11 October 2016

9:00
Welcome and Introduction
Session 1: Trends in Pharmaceutical Supply Chain
Georg Roessling, PDA Europe

Erik van Asselt, MSD, Conference Co-Chair
Rafik Bishara, Technical Advisor, Conference Co-Chair
Moderator: Rafik Bishara,
Technical Advisor
Many factors can impact the product integrity in the pharmaceutical supply chain. Patient health and compliance to GMP/GDP regulation
are two factors that drive the supply chains to implement secured and temperature controlled processes. But what others important
trends, risks and factors impact the supply chains?
9:15
Ensuring a Secured and Temperature Controlled Pharma Supply

Chain
9:45
Global PCCIG Activities & Update from the US Pharmacopoeia (USP) Rafik H. Bishara,
Technical Advisor,
Chair of PCCIG US Branch
10:15
Coffee Break, Poster Session & Exhibition
Session 2: Transport Risk Mitigation
Erik van Asselt,

MSD, Chair of PCCIG EU Branch
Moderator: Georg Roessling,

PDA Europe
This session deals with risk management in GDP. Examples how this can be done in a practical manner will be given. Topics covered
will be: Mapping of the end-to-end supply chain, process, technical and personnel aspects, including compliance with international
standards and customer requirements.
10:45
Pharma by Air:
Equipment Qualification and Route Risk Assessment
Zvonimir Majic,
TEVA, PCCIG
11:15
Risk Management for Cold Chain Distribution:

A Pragmatic Approach. Integrating business needs while ensuring
compliance and continuity in supply
Fabian de Paoli,
GSK
11:45
The Human Side of Lane Qualification the Mock Shipment Call
Jim Bacon,
American Aerogel
12:15
Route Risk Assessment for Road Transport
Heidi Leponiemi,
Oriola-KD
12:45
Q & A, Discussion
13:00
Lunch Break, Poster Session & Exhibition
Session 3: Innovations in Ocean Freight
Moderator: Erik van Asselt,

MSD
To drive transport cost down, shipping by ocean is an option as alternative for airfreight. However, shipping by ocean has challenges in
supply chain lead times and temperature control that require diving deeper into exploring innovative solutions. This session will present
some of the highlights of that sector.
14:00
Temperature Control and Reefer Handling Procedures
Gareth Madsen,
Maersk
CONFERENCE AGENDA
14:30
Air to Ocean: Cold Chain Challenges for Vaccines
Jeroen Janssens,
GSK
15:00
Factors Affecting Temperatures in Seagoing Reefer Containers
Leo Lukasse,
University of Wageningen
15:30
16:00
Thermal Protection Kit for Ocean Shipments
Thomas de Bie,
CAPPI
16:30
Best Practices: GDP Qualification of Sea Containers for

Transportation of Pharmaceutical Products
Essangui Mbaitjongue,
ThermoKing
17:00
Q&A, Round Table Discussion
Sessions Speakers
18:00
End of Day & Networking Reception
The Parenteral Drug Association invites you to join our
Networking Reception
CONFERENCE AGENDA
Wednesday, 12 October 2016
Session 4: Supply Chain Integrity: Security & Serialization
Moderator: Monika Derecque,

GIRP
It is now clear that by early 2019, every pharmaceutical manufacturer supplying medicinal products in Europe needs to have adapted their
packaging, implemented tamper evidence capability, and have established systems, processes and master data to be in full compliance
with the EU-Falsified Medicines Directive. This session aims to understand the challenges and ways of how to execute this implementation.
8:00
Manufacturers Responsibilities under the Delegated Regulation

and Falsified Medicines Directive
Elisabeth Sandqvist,
EFPIA
8:30
Impact of Falsified Medicines Directive on Manufacturers

Operations Practical Examples
Joan Cahill,
Pfizer
9:00
Verification of Medicinal Products in Europe Where do we Stand
Andreas Walter,
EMVO
9:30
Q&A, Panel Discussion
10:00
Session 5: Developments in Airfreight
Moderator: Nina Heinz,

DHL
Ensuring GDP compliance during transportation by air is one of the most challenging but also an area of constant improvement,
investment and innovation. Hear from our industry experts on different methods and best practices to mitigate the risk to time and
temperature sensitive life sciences shipments.
10:30
Developing Cold Chain Contingency Infrastructures at Airports:

Lessons Learned along the Journey
Christelle Laot,
FedEx
11:00
Operationalizing Big Data: The New Face of Risk Management

in the Smarter Cold Chain
Federico Lupp,
DHL
11:30
Cargo Cover Performance under Real Environmental Conditions
Steve Brabbs,
DuPont
12:00
Lunch Break, Poster Session & Exhibition
Session 6: GDP Compliance
Moderator: Rafik Bishara,

Technical Advisor
This session will provide industry perspectives on the implementation of GDP as well as inspectors perspectives on the challenges before
giving attendees the opportunity to address specific questions.
10
13:00
GDP-Compliance in Europe: A Status Report about the

Implementation of the GDP-Requirements in the
Pharma-Supply-Chain
Achim Bundschuh,
Consultant
13:30
New Regulatory Requirements for API Manufacturers

A View on GDP Compliance Expectations
Ivica Komoar,
TEVA
14:00
Stability of Oxytocin along the Supply Chain
Umit Kartoglu,
WHO
14:45
Refreshment Break
CONFERENCE AGENDA
15:00
Q&A, Discussion with Regulatory and Industry Representatives:

Challenges of GDP Implementation
Panelists include
Umit Kartoglu, WHO
16:30
Riekert Bruinink, The Netherlands
Achim Bundschuh, Consultant
Ivica Komoar, TEVA
Service Providers from the Exhibition Floor
Summary, Farewell Remarks & End of Conference
11
The Parenteral Drug Association presents...
PDA Education
Program
13-14 October
Two-Day Training Course
Erik van Asselt, PhD,

MSD, Leader PCCIG Europe Branch
Rafik H. Bishara, PhD,
Eli Lilly (retired), Leader PCCIG USA Branch
Richard Harrop,
Topa Thermal Packaging
Kieran OConnor,
Freightwatch International
Stefan Surpitski,
Freightwatch International
13 October
Good Qualification Practice of
Pharma Storage and
Transportation Equipment
One-Day Training Course
Achim Bundschuh,
Consultant
14 October
Supply Chain Strategies for
API and Drug Product
12
Hiltrud Horn, PhD,

Managing Director,
HORN Pharmaceutical Consulting
TWO-DAY TRAINING COURSE
B as e d
on PDA
Techn
Repor t ical
s 53,
an d 7 2 5 8
Overview
The successful Four Modules Training will be held following the PDA Europe Conference on
Cold & Supply Chain Logistics. In this interactive course, trainees have the opportunity to
learn the best secure cold chain practices from an international field of experts.
The first day will be held at the facility of Topa Thermal Packaging and includes a tour of
the climate chambers and the mechanical test laboratory. Participants will get insights into
Design and Qualification of Containers, Distribution Testing, and Packaging of Shippers
The second day will cover supply chain cargo security and visibility industry best practices demonstrating supply chain integrity, temperature monitoring and data analysis, stability budget for the supply chain, and temperature and transport risk management.
Please join, connect, learn, share your views, experiences and implement the usage of the
related PDA Technical Reports #53, 58 and 72.
Statement by Topa:
Day 1 of the PDA Europe Secure Cold Chain Practices training course is to be held at the Topa Thermal
Packaging facility in Voorhout, The Netherlands. As part of the course agenda, Topa Thermal Packaging will allow access to their product development and packaging testing centers, as well as share
information related to their activities and processes. Due to the nature of what will be shared, Topa
Thermal Packaging will be unable to permit entry to registrants who work for competing organizations.
Faculty
Erik van Asselt, PhD MSD, Leader PCCIG Europe Branch
Rafik H. Bishara, PhD Eli Lilly (retired), Leader PCCIG USA Branch
Richard Harrop, Topa Thermal Packaging
Kieran OConnor, Freightwatch International
Stefan Surpitski, Freightwatch International
Please
hoes
bring flat s
safe
which allow
the
walking in
Topa lab!
13
SECURE COLD CHAIN PRACTICES

Thursday, 13 October 2016
14
At Topa Facility in Voorhout
8:00
Bus Transfer from Novotel Amsterdam Schiphol Airport to Topa, Voorhout
9:00
Welcome
9:30
Module 1: Design and Qualification of Containers

An introduction to different material types used in the development
of thermal packaging, following up with a look at the process of
qualification. PDA Technical Report 72 will be discussed as well.
11:00
Coffee Break
11:15
Class exercise 1 Designing the Solution

An interactive exercise where participants will be split into teams and
then given a brief with a requirement to design a thermal
packaging solution
12:15
Lunch Break
13:00
Class exercise 2 Documentation and Climate Chambers

The teams will be introduced to the climate test chamber.
They will then work with the Topa Institute engineers to assemble
their designs from exercise 1 and then run a thermal test on them
within a climate chamber.
Richard Harrop &

Topa Engineers
14:00
Distribution Testing
An introduction presentation that highlights the processes of
distribution testing and its value when added to a thermal
packaging qualification process.
Richard Harrop
14:30
Coffee Break
14:45
Class exercise 3 The Mechanical Lab

A tour of the distribution test facility by members of the Topa
Institute, followed by an interactive exercise aimed to highlight
the importance of distribution testing during the development of
thermal packaging.
Richard Harrop &

Topa Engineers
16:15
Wrap up and Roundtable Discussion

An open discussion where the days activities can be reviewed
and where any final questions can be asked
Richard Harrop,
Erik van Asselt,
Rafik H. Bishara
17:00
Closing of Day 1 & Reception
18:00
Return to Novotel Amsterdam Schiphol Airport by Bus
Richard Harrop
Richard Harrop,
Erik van Asselt,
Rafik H. Bishara
TRAINING COURSE AGENDA

Friday, 14 October 2016
At Novotel Amsterdam Schiphol Airport
8:00
Module 2, Part A: Supply Chain Cargo Security and Visibility

Industry Best Practices Demonstrating Supply Chain Integrity
The Importance of cargo theft intelligence
TAPA / Rx360 and other relevant industry guidelines / standards
Foundations of a Security Culture: Audits and Assessments of
Facility and Carrier
10:00
Coffee Break
10:15
Module 2, Part B: Supply Chain Cargo Security and Visibility

Ongoing monitoring and continuous improvement programs
Recommended industry best practices for securing cargo in-transit
Why a layered approach to ensuring cargo security
Case Study hypothetical cargo theft scenario. Solutions and
recommendations.
Kieran OConnor,
Stefan Surpitski
11:45
Review of Temperature Performance of Designed Packouts of Day 1

The design of thermal packaging solutions determine the performance
and thermal protection of products. Temperature inside the packouts
of Day 1 will be compared, reviewed and discussed.
Erik van Asselt,

Richard Harrop
12:15
Lunch Break
13:00
Module 3: Stability Budget for the Supply Chain

Provides tools and methodology to assign the amount of time out of
storage (TOS) that a drug substance may experience without any significant risk to its quality, efficacy and potency. Discussion and training
basis is PDA Technical Report 53 on Stability Testing.
14:30
Coffee Break
15:00
Module 4: Temperature and Transport Risk Management

Trainees will be introduced to tools to help them in the risk management of temperature and transport deviations. ICH Q9 on Quality Risk
Management and PDA Technical Report 58 on Risk Management for
Temperature Controlled Distribution will be reviewed.
Erik van Asselt,

Rafik H. Bishara
16:30
Wrap Up
Erik van Asselt,

Rafik H. Bishara,
Richard Harrop,
Kieran OConnor,
Stefan Surpitski
16:45
End of Training Course
Kieran OConnor,
Stefan Surpitski
Rafik H. Bishara
15
ONE-DAY TRAINING COURSE
Good Qualification Practice

of Pharma Storage and
Transportation Equipment
Overview
The EU GDP Guidelines have been designed and extensively revised to take into consideration the changing nature of globalized pharma-supply-chains. One elementary aspect is that medicinal products should
be handled, transported and stored with qualified equipment. During the training course the requirements of the existing guidelines and regulations on equipment qualification will be reviewed and discussed. In the following the general and typical steps of equipment and warehouse qualification will be
demonstrated. In workgroups the participants will specify the requirements and prepare a draft qualification plan for a storage room and a transport vehicle for pharmaceuticals. Some practical examples will
show, how a state-of-the-art-qualification should look like. Finally the systems to be implemented in
combination with the equipment and the procedures to be established in order to operate the qualified
equipment will be jointly worked out in the group. A final Q&A-session will close the training.
Who Should Attend
The training course is designed for all managers, supervisors and staff members who are involved
in the quality- or logistics-management of pharmaceutical storage, transportation and distribution
activities for both, pharmaceutical and logistics companie. Target audience/participants are e.g.:
Manager Quality Logistics (Road, Sea, Air)
Distribution-Network- and Warehouse-Managers
Quality Assurance Agents
Fleet-Managers
Logistics Manager Pharma-Storage and Transportation
Procurement Managers Logistics
Learning Objectives
Upon completion of this workshop, you will be able to:
Understand the requirements of existing guidelines and regulations on pharma storage and transportation equipment
Get an overview of state-of-the-art-equipment based on practical examples
Understand the steps of the qualification of pharma storage rooms and of equipment for the transportation of medicinal products
Learn to plan and co-ordinate qualification-projects and to face the various challenges of equipment
qualification
Be able to evaluate the GDP-readiness (equipment, procedures, stuff) of their warehouse- and transportation-service-providers
16

Thursday, 13 October 2016
9:00
Welcome, objectives and procedure of the training
9:15
Review of the requirements of regulations and guidelines

on equipment qualification for the pharma storage and
transportation
9:45
QUALIFICATION BASICS
Elements, typical steps and common procedure of
equipment qualification
Differences between warehouse and vehicle qualification
State-Of-The-Art-Examples
11:15
Coffee Break
11:45
Preparation of the requirements and a qualification plan

for a storage room and a vehicle qualification
13:00
Lunch Break
14:00
Presentation and discussion of the workgroup-results
15:00
Procedures for the operation of qualified pharma storage

rooms and transport equipment
16:15
Coffee Break
16:45
Peripheral equipment and computerized systems for

warehousing and transportation of medicinal products
17:30
Q&A, closing comments
18:00
9:00 18:00
WORKGROUP
SESSION
PRESENTATION BY
THE WORKGROUPS
Faculty
Achim Bundschuh, Consultant
Achim Bundschuh - entrepreneur, independent consult and interim manager. His fields of activities are Supplier Qualification, Auditing, QM-System-Implementation, CS-Validation and Pharma-Logistics-Strategy. His main objectives
are to translate existing laws and guidelines into manageable procedures and to mediate between the various
parties involved in the pharma-supply-chain by creating minimum and practical standards for the storage and transportation of medicinal products. He supports pharmaceutical companies as well as logistics service providers with
his profound experiences. Before he worked as an independent consultant he was Managing Director and shareholder of several
companies specialized on pharma- and temperature-controlled logistics and held several senior positions in Germany and Hungary.
17

9:00 17:30
Supply Chain Strategies for API

and Drug Product
Overview
Setting up the supply chain gets more and more complex based on changes in pharmaceutical industry.
In order to respond in a flexible, efficient and cost-effective way to the needs of the market additional
manufacturing sites are needed for the manufacture of starting materials, active pharmaceutical ingredients as well as drug products.
The phase of development and also the complexity of the process need to be considered prior to starting a site transfer project. Furthermore, all these changes take place within a well-controlled GMP and
regulatory environment that needs to be understood in order to define the right outsourcing strategy for
pharmaceuticals which are marketed globally.
The cross-functional team or typically CMC-team is involved in series of decisions, and needs to come up
with the right strategy to fulfill the needs of the market. Technology transfers can happen within pharmaceutical companies covering different sites, but also between different manufacturing sites from various
contract manufacturers. The selection of the right CMO (contract manufacturing organization), their ability to produce high quality product considering current GMPs and regulatory requirements is of utmost importance for a successful start of the project. In addition to site transfers for the manufacturing process,
transfers of analytical methods need to be considered and carefully planned.
The teams responsibility is to define all necessary tasks for the site transfer and to ensure that all necessary documents are being made available. While QA performs the necessary audits and does the
GMP-agreements, regulatory affairs experts take care of the regulatory strategy and the necessary documentation that needs to be submitted to regulatory Authorities. Production and analytics deliver the new
product and also decide about the validation strategy and finally provide the results that are necessary
for comparability reasons. Key to success is a good interaction and planning within the team considering
the expertise of the involved individuals.
Key-points of discussion with in teams are often comparability of the product (prior and after the change),
documentation needs, potential inspections timing, costs and risks associated with the transfer.
This 1-day training course covers the essentials you should know to manage outsourcing with high
quality and in time. It is an interactive training course consisting of presentations, open discussions,
case studies and includes a workshop in which you can develop your own strategy and improve your
project management skills.
You will get hands-on experience from your trainer who will provide you many examples from over 26
years of experience in pharma industry. Join us at this event and benefit for all your future projects.
18

Who Should Attend
This course will focus on individuals that have input into supply chain management decisions, or
who have oversight or actively manage technology transfers in EU or US. This includes the following
functions within pharmaceutical or biotech industry including drug substance manufacturers:
Supply Chain Management
SPECIFIC JOB FUNCTIONS:
Project Management
Supply Chain Manager
Manufacturing & Technical Operations
Project Managers
Analytical Development
CMC-Team Leaders
Quality Control
Manager/Leader/Supervisors in Manufacturing
and QC/QA
Quality Assurance
Regulatory Affairs
Research & Process Development
Marketing
Researcher/Technician
Regulatory Affairs Specialists
Strategists
Engeneering
Learning Objectives
Upon completion of this workshop, you will be able to:
Set up your supply chain successfully
Understand the essential principles for starting outsourcing activities
Know the necessary GMP and regulatory background
Design the right strategy for outsourcing
Set up a technology transfer successfully
Organize the essential document needed to start process transfers
Balance the outsourcing risks for your product considering different phases of development
Find solutions to cope with the unexpected during transfers
Perform proper project management to achieve your milestones in time
Guide your team successfully through all phases of outsourcing activities
Prepare for inspections considering involved contract labs and CMOs
Organize your project efficiently and complete it in time
Faculty
Hiltrud Horn, PhD, Managing Director, HORN Pharmaceutical Consulting
Hiltrud Horn, the founder and managing director of HORN Pharmaceutical Consulting. She has more than 26 years
of experience in the pharmaceutical and biotechnology industry (EU and US). Her company provides consulting services for the pharmaceutical and biotech industry with focus on chemistry, manufacturing and controls (CMC), good
manufacturing practices (GMP), compliance and regulatory affairs (EU, US). The consulting activities cover various
kinds of drug substances and drug products, ranging from small molecules and peptides, to biological and biotechnology derived products (e.g. antibodies, proteins, vaccines, etc.) and ATMPs. Hiltrud is an expert in Regulatory
Affairs, CMC and GMP, and is a regularly invited speaker at conferences on CMC / GMP as well as on the development and registration
of new chemical entities, biotechnological products and ATMPs. She has successfully managed many GMP and Regulatory Affairs projects in EU and US in various big, medium-sized and small pharmaceutical companies. Hiltrud is pharmacist and holds a PhD degree in
Human Biology from the University of Ulm. Furthermore, she has an ECPM-Diploma (Diploma in Pharmaceutical Medicine) from Eucor
University Basel, European Centre for Pharmaceutical Medicine. Dr. Horn has additional qualification as Pharmaceutical Expert for
Drug Information and as Pharmaceutical Expert for Pharmaceutical Analytics.
19

9:00
Module 1:
Outsourcing Strategies for EU and US

10:45
Coffee Break
How to set up your strategy?

When is the right time for outsourcing?
Which are the key-aspects to be considered at different stages of development?
What is essential from a GMP and regulatory perspective in EU and US?
Process Transfers of Drug Substances & Drug Product
11:15
12:45
Lunch Break
Module 3:
How to plan a Process Transfer?

What are the essential parts of Technology Transfer Package?
How can you minimize Risks and Delays?
Typical Examples (Drug Substance, Tablets, Sterile Product)
Workshop: Project Management for a Typical Technology Transfer Project
13:30
Planning
Key-Milestones
Documentation
15:15
Coffee Break
Module 4:
15:30
Module 5:
20
Welcome & Introduction
9:15
Module 2:
9:00 17:30
Outsourcing: QC and QA-Perspective

When will you outsource analytics and why?

How will you choose your Contract Lab?
What are the points to be considered for an analytical transfer?
What needs to be considered for the GMP-Agreement?
What is essential for inspections?
Outsourcing: Success Factors
16:30
How will you select and evaluate your potential partners?

How will you monitor the transfer activities?
How will you cope with unplanned changes?
How can you manage your project successfully?
17:15
Summary of the Day
17:30
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Registration Form Page 1
For contact at PDA Europe

PDA Europe Conference, Exhibition, IG Meeting, Workshop, Training Courses
Pharmaceutical Cold & Supply Chain Logistics
This PDF-file provides an automatic

fill-in function. Your signature,
however, is needed in writing.
11-12 October 2016 | Amsterdam | The Netherlands
Your registration is only complete upon filling in and submitting both pages of this form.
Registration
No PDA membership included
EARLY BIRD DISCOUNT
Book by 11 Sept. to receive 150* off the conference fee only
All fees given in Euro, excluding VAT (21 %)
10 October
Tour A*
net
On-site Workshop Pharma by Road &

Site Visit Panalpina/Wordwide Flight Service (WFS)
All Participants
200
*FREE with conference registration before 31 August
10 October
Tour B*
net
Site Visits
DHL Life Science Competence Center & Envirotainer
All Participants
200
*FREE with conference registration before 31 August
11-12 October
Conference only

* Early Bird 670
13 October
Good Qualification Practice of

Pharma Storage and Transportation Equipment
13-14 October
Two-Day Training Course

14 October
Conference Fee
net
PDA Member
1495
Nonmember
1745
Regulatory/Academic
750
Training Course Fee
net
All Participants
695
Training Course Fee
net
All Participants
Supply Chain Strategies for API and Drug Product
1495
Training Course Fee
net
All Participants
695
The fee includes course documentation as well as mid-session refreshments and lunch.
Excellent networking opportunities with snacks and drinks will be provided.
The fee does not include the hotel accommodation. PDA Europe has secured a limited number of rooms at a special group rate.
Group Registration Discount

Register 5 colleagues for the conference at the same time and receive the 5th registration free. For more information on group discounts please contact us at registration-europe@pda.org. Other discounts cannot be applied.
Discount for Exhibiting Companies
Join PDA and receive the

Membership Rate Today!
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Please mark here if your company is an exhibitor to this event and you will receive the conference ticket at the special price of 995 Euro
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22
Registration Form Page 2
For contact at PDA Europe

PDA Europe Conference, Exhibition, Workshops, Training Courses
This PDF-file provides an automatic

fill-in function. Your signature,
however, is needed in writing.

11-12 October 2016 | Amsterdam | The Netherlands
4 WAYS
TO REGISTER
1
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3
4
ONLINE: https://europe.pda.org/URLevent2015
FAX: +49 30 4365508-66
EMAIL: registration-europe@pda.org
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23
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THANK YOU FOR YOUR COOPERATION!

2016 PDA EUROPE ACTIVITIES & EVENTS

27-28 September
29 September
29-30 September
Pharmaceutical Freeze Drying Technology | Conference

Application of a Risk-Based Approach to Freeze-Drying Processes
Development of a Freeze Drying Process
5-6 October
Current Challenges in Aseptic Processing, Potential Changes in

EMA/PIC/S Annex 1 Revision
TC
WS
Strasbourg, France
WS
Dublin, Ireland
TC
13-14 October
14 October
Schiphol Airport Site Visit & On-Site Workshop Pharma by Road

Pharmaceutical Cold & Supply Chain Logistics | Conference
Good Qualification Practice of Pharma Storage & Transportation
Equipment
Supply Chain Strategies for API and Drug Product
24 October
25-26 October
27-28 October
27 October
Particle Identification in Parenterals

Visual Inspection Forum
An Introduction to Visual Inspection: A Hands-on Course
Testmethoden fr vorbefllte Spritzen (PFS)
TC
8-9 November
Data Integrity
WS
14 November
15-16 November
17 November
17-18 November
17-18 November
17-18 November
17-18 November
Managing Single- and Multi-Source Supply Chain Challenges

Outsourcing & Contract Manufacturing | Conference
Quality by Design for Biopharmaceuticals
Practical Guide for Root Cause Investigations Methodology & Tool Kit
Outsourcing, Technology Transfer, and CMO-Client Relationships
Risk Management in Technology Transfer
Basics of Successful Auditing
TC
24-25 November
Track und Trace-Implementierung von Serialisierung
TC
10 October
11-12 October
13 October
TC
TC
TC
TC
TC
TC
WS
TC
TC
WS
Amsterdam,
The Netherlands
Berlin, Germany
Berlin, Germany
Barcelona, Spain
Leipzig, Germany
2017 PDA EUROPE CONFERENCES

14 15 February
Pharmaceutical Microbiology
Porto, Portugal
14 15 March
Parenteral Packaging
Barcelona, Spain
26 27 April
Current Trends in Aseptic Fill & Finish of Prefilled Syringes
Ravensburg,
Germany
30 May 1 June
Virus & TSE Safety Forum
Dubrovnik, Croatia
13 14 June
2nd PDA Europe Annual Meeting
Berlin, Germany
27 28 June
Advanced Therapy Medicinal Products
Valencia, Spain
19 20 September Pharmaceutical Freeze Drying Technology
Cologne, Germany
26 27 September 10 th Workshop on Monoclonal Antibodies
Berlin, Germany
10 11 October
Rotterdam,
Netherlands
7 - 8 November
The Universe of Pre-filled Syringes and Injection Devices
Vienna, Austria
21 22 November
Outsourcing & Contract Manufacturing
tbc
Subject to change
For latest info: europe.pda.org
Shortlist 28 September 2016
General Information
PDA Europe gGmbH
Am Borsigturm 60
13507 Berlin, Germany
Tel: +49 30 4365508-0
Fax: +49 30 4365508-66
Conference Information
Melanie Decker
Director Events & Exhibitions
Tel: + 49 30 4365508-19
decker@pda.org
Training Course Information

Elke von Laufenberg
Manager Training & Education
Tel: + 49 30 4365508-21
laufenberg@pda.org
Legend
IG Interest Group Meeting
TC Training Course
WS Workshop
www.europe.pda.org

Pharma Cold Chain Logistics

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The Parenteral Drug Association presents:

2016 PDA Europe

Pharmaceutical Cold &

11-12 October 2016

Novotel Amsterdam Schiphol Airport

Amsterdam | The Netherlands

SCHIPHOL AIRPORT SITE VISIT

PDA Europe Schiphol Airport Site Visit

Joint Departure: Bus Transfer provided by Envirotainer

Lunch provided by Schiphol Airport

Workshop Pharma by Road (please see this brochure for details)

Bus Transfer and Site Visit of Panalpina & WFS

Bus Transfer returning to Schiphol Airport Offices

Site Visits to DHL Life Science Competence Center + Envirotainer

Lunch provided by DHL Global Forwarding

Presentation & Site Visit DHL Life Science Competence Center

Bus Transfer and Site Visit of Envirotainer

Bus Transfer returning to Schiphol Airport Offices

Welcome Reception provided by Schiphol Airport

Bus Transfer returning to Conference Hotel

SCHIPHOL AIRPORT SITE VISIT

Schiphol Airport Site Visit Partners

Are your pharmaceuticals

Now its easy to know with the industrys only validated

LETTER FROM THE CO-CHAIRS

Erik van Asselt

PROGRAM PL ANNING COMMITTEE

4 Monica Derecque-Pois, GIRP

Housing at the selected hotel will be in high demand, so

Special offer: Discounted travel with Lufthansa Group Airlines

Tuesday, 11 October 2016

Welcome and Introduction

Session 1: Trends in Pharmaceutical Supply Chain

Georg Roessling, PDA Europe

Ensuring a Secured and Temperature Controlled Pharma Supply

Coffee Break, Poster Session & Exhibition

Session 2: Transport Risk Mitigation

Erik van Asselt,

Moderator: Georg Roessling,

Risk Management for Cold Chain Distribution:

The Human Side of Lane Qualification the Mock Shipment Call

Route Risk Assessment for Road Transport

Lunch Break, Poster Session & Exhibition

Session 3: Innovations in Ocean Freight

Moderator: Erik van Asselt,

Temperature Control and Reefer Handling Procedures

Air to Ocean: Cold Chain Challenges for Vaccines

Factors Affecting Temperatures in Seagoing Reefer Containers

Coffee Break, Poster Session & Exhibition

Thermal Protection Kit for Ocean Shipments

Best Practices: GDP Qualification of Sea Containers for

Q&A, Round Table Discussion

End of Day & Networking Reception

The Parenteral Drug Association invites you to join our

Moderator: Monika Derecque,

Manufacturers Responsibilities under the Delegated Regulation

Impact of Falsified Medicines Directive on Manufacturers

Verification of Medicinal Products in Europe Where do we Stand

Q&A, Panel Discussion

Coffee Break, Poster Session & Exhibition

Session 5: Developments in Airfreight

Moderator: Nina Heinz,

Developing Cold Chain Contingency Infrastructures at Airports: