the pharmaceutical & healthcare sciences society

INDIA Conference & Exhibition

Two Day Technical Conference on Bio-Contamination Control and Developments in Process Equipment

Photo supplied by Steris

Photo supplied by IMA Life

Tuesday Venue:

4th and Wednesday 5th December 2012

Novotel Hyderabad Convention Centre

Photo supplied by Steriline

Two Day Technical Conference on Bio-Contamination Control and Developments in Process Equipment.
The PHSS is a Not for Profit scientific society based in Europe (UK) but have an international profile of providing training, seminar and conference events to facilitate knowledge exchange between Life Science and Healthcare professionals. The PHSS also form special interest groups that prepare technical monographs and best practice (How to achieve) guidance documents in support of regulatory requirements of the FDA, MHRA and other international regulatory bodies. The PHSS have a peer reviewed quarterly journal European Journal of Parenteral and Pharmaceutical Science (EJPPS) issued free of charge to all PHSS members. The journal includes scientific peer reviewed articles, technology features, a well respected international regulatory update together with reports on PHSS initiatives and activities including special interest group reports from India and around the world. The PHSS have a peer reviewed quarterly journal European Journal of Parenteral and Pharmaceutical Science (EJPPS) issued free of charge to all PHSS members. The journal includes scientific peer reviewed articles, technology features, a well respected international regulatory update together with reports on PHSS initiatives and activities including special interest group reports from India and around the world. Members of the India Special Interest Group: Alok Ghosh, Lupin Pharma Limited KVGK Raju Gland Pharma Limited Sunil Singhai Dr. Reddys Laboratories Limited Sampad Bhattacharya Sun Pharma Limited Nilanjana Basu Lupin Pharma Limited Madhu Raju Saghee Gland Pharma Limited Satish Joshi Hospira India Limited Dr. Anand Kumar Indian Immunologicals Ltd. Sanjay Singh Aurobindo Pharma Limited Sanjit Singh Lamba Eisai Pharma Limited Amit Rajan Celogen DB Sridhar Ranbaxy Limited Sundhar CK Strides Arcolab Limited Sridhar Balasubramanian Dr. Reddys Laboratories Limited Rajesh Thempadiyil Dr. Reddys Laboratories Limited Antony Raj Gomas Mylan India Limited Mr K V Raju Hospira India Limited Visesh Parekh Income Group Following the formation of the principle PHSS India Special interest group (I-SIG) for Education in Pharmaceutical, Biopharmaceutical, Healthcare and life sciences the PHSS are pleased to provide a two day conference session, Led by eminent European speakers, including the PHSS Chairman, providing information on latest developments and best practice. Local specialists from India and members of the I-SIG will also support this conference in India. The International Society for Lyophilisation-freeze drying are providing a speaker for the Freeze drying session. The two day training course is to be held at the Hotel Hyderabad, 4 / 5 December and will include table top exhibitions from a number of suppliers of related equipment and services. The course theme this year will cover key topics: Bio-contamination control and monitoring of processing environments and developments in process equipment used in GMP and life science applications. Not an event to be missed Book early.

12.30pm 2.00pm Lunch served and lunch break viewing Exhibition. 2.00pm 3.00pm. Latest Developments in Environmental monitoring for Cleanrooms and Barrier Separation. Technology Isolators & RABS Restricted Access Barrier Systems. John Wallingford PHSS SIG Member and Director Pharmagraph UK Ltd.

Holistic view of environmental monitoring and latest developments. Monitoring Cleanroom pressure Differentials, Temperature & relative humidity. Monitoring particulate levels to ISO standards including Classification and Continuous Real time Particle monitoring for GMP compliance. Monitoring viable bio-burden (airborne and surface) and improved sampling control, analysis and data trending / reporting.

3.00pm 4.00pm. Integrity testing:- Barrier Separation Technology (Isolators & RABS), Barrier Gloves and HEPA filters that form part of controlled area barriers (Cleanrooms & Separative Devices). Tim Triggs PHSS Management team member and Director DOP solutions Ltd & Academy of Compliance Training (Act) UK.
Leak integrity testing of controlled barriers using Pressure Decay and Pressure Hold test methods. Requirements for Classification and Monitoring Leak integrity and how they differ, including recommended acceptance criteria. Integrity testing of HEPA Filters; Requirements, frequency and methods for Barrier devices and Cleanrooms.

4.00pm 4.15pm Short afternoon break. 4.15pm 5.15pm. Bio-contamination events and deviation management. James Drinkwater PHSS Chairman and Special Interest Group Leader for Bio-contamination Characterisation, Control and monitoring.
Bio-contamination events and related characterisation and microbiological identification. Microbiological deviation management; Root cause Analysis (RCA) Best practice for compliance. Corrective and Preventative Action (CAPA) Guidance on procedures and implementation.

5.15pm Chairmans closing remarks and Day one Training close

Day 2: Hyderabad December 5th

Registration and reviewing exhibition from 8.00am. 8.45am Opening Welcome. Madhu Raju Saghee: Director of PHSS India Special Interest Group for Education & PHSS Chairmans welcome and opening remarks, introduction about PHSS & recent enforcement trends.

Topic Sessions Day (1): Bio-contamination control and monitoring

will consider requirements and best practice for contamination control in processing environments for Aseptic, Toxic and biological products together with barrier separation technology. Aspects of Standards, requirements and technology for controlled environments and containment to protect products and operators from direct contamination and cross contamination will be presented. In addition important information will be provided on managing Bio-contamination events with Route cause analysis (RCA) and Corrective and Preventative Action (CAPA).

Process Equipment for GMP applications

9.00am 10.00am. Moist Heat Sterilisation. Alan G Heavey: Consultant & Specialist: Sterilization Solutions Limited UK.
Acceptance Criteria challenges. Cycle design. Good business sense.

Topic sessions Day (2): Developments in Process equipments

will include updates on latest developments in:
Autoclave Moist heat Sterilisation Water systems for Pharmaceutical / Biopharmaceutical applications Manufacturing Execution Systems, Electronic Batch Recording Freeze dryers Lyophilisation Filling Pharmaceuticals / Biological products at different levels of scale and requirement including Aseptic Toxic and Biological products Sterility Testing and Rapid Microbiological Methods (RMM)

10.00am 11.00am. Developments in Water systems for GMP / Life Science applications. Phillip Greaves: Consultant: BiotiQ Consulting.
Water system concepts for GMP life Science applications. Sterilisation and contamination control plus managing Bio-films in Water systems Rouge in Water systems.

11.00am 11.30am Coffee Break and viewing Exhibition. 11.30am 12.30pm. Manufacturing Execution Systems (MES) - Electronic Batch Recording. Rajesh Thempadiyil: Computerized System Validation Dr Reddys Laboratories Limited.
Introduction to Manufacturing Execution System and levels of automation. Shift in Paradigm Manual to Electronic. Manufacturing Execution Systems (MES) Electronic Batching and Recording. Implementation strategies and challenges.

Day 1: Hyderabad December 4th

Registration and reviewing exhibition from 8.00am. Training Program: Bio-contamination Control & Monitoring course start at 9.00am. 9.00am Opening Welcome. Madhu Raju Saghee: Director of PHSS India Special Interest Group for Education & PHSS Chairmans welcome and opening remarks, introduction about PHSS & recent enforcement trends.

12.30pm 2.00pm Lunch served and lunch break viewing Exhibition. 2.00pm 3.00pm. Latest Developments in Freeze drying - Lyophilisation. Mr S Mohan, Asst. National Service Manager Spinco Biotech.
Emerging Techniques for Cycle Optimization Controlled Nucleation for Product Quality Improvement Optimization and Scale-up Considerations in Freeze Drying Automated Vial Loading/Unloading System Types and Developments

Bio-contamination Control & Monitoring sessions

9.30am 10.15am. Challenges and Solutions in applying Barrier Separation technology, Isolators and RABS, in processing Toxic and/or Biological products. James Drinkwater PHSS Chairman and Bioquell UK Bio-decontamination solutions Process & Compliance Director.
The Challenges in processing Toxic and Biological products. Barrier Separation Technology concepts for processing Toxic and Biological products. Compatibilities and analytical study methods for Bio-decontamination agents and Biological products that are processed Aseptically, Including considerations of Hydrogen peroxide Vapour oxidizing potential compatibility.

3.00pm 4.00pm. Integrated Filling Lines for Aseptic Filling, Filling of Toxic and Biological products including Freeze drying and Filling Lines under Isolators or RABS. Provided by IMA Life: Specialist Production and Small scale Filling of Medicinal and Therapeutic products.
Developments in Filling of Medicinal and Therapeutic Products. Special considerations when filling Toxic and/or Biological products. Integrated Filling Lines and zone control philosophies.

10.15am 11.00am. Developing ISO standards and guidance that will significantly impact GMP / Life sciences. Tim Triggs PHSS Management team member and Director DOP solutions Ltd & Academy of Compliance Training (Act) UK.
ISO standard connection to GMP . Updates of ISO 14644 (Classified controlled environments) and ISO 14698 (Bio-contamination airborne and surface classifications). PHSS Bio-contamination characterization, control and monitoring in controlled areas new PHSS monograph.

4.00pm 4.15pm Short afternoon break. 4.15pm 5.15pm. Developments of Sterility testing in Isolators. James Drinkwater PHSS Chairman and Special Interest Group Leader for PHSS Pharmacy Isolator QRM guidance.
Principle requirements for Sterility Testing and application in Isolators. Rapid Bio-decontamination of Test materials for rapid processing. Considerations in Rapid Microbiological Methods (RMM) and application in Sterility Testing.

11.00am 11.30am Coffee Break and viewing Exhibition. 11.30am 12.30pm. Challenges for autoclave compliance. Alan G Heavey: Consultant & Specialist: Sterilization Solutions Limited UK.
Steam sterilisation overview Steam quality and testing SIP

Closing remarks from Madhu Raju Saghee. Gland Pharma India. 5.15pm Director of PHSS India Special interest Group (PHSS I-SIG) for Education & PHSS Chairmans closing thanks and Day Two Training course close

Learning Objectives:
a. b. c. d. e.

In a span of just two days, participants will have increased knowledge in:

Regulatory requirements and enforcement trends. Developments in standards and guidance that will impact all involved in Life sciences New technologies and best practice in bio-contamination control and monitoring Understand the latest developments in process equipment used in GMP applications. PHSS educational activity in India and upcoming events.

Who Should Attend:

All those involved in Quality Assurance, Production, Sterility test, process and product development or related support services that have an interest in Bio-contamination control to classification levels, bioburden control related to biologics, Aseptic processing and the current status and developments in process equipment technologies used for GMP and life sciences applications.

General Information:

All conferences attended will be available for those who are registered with PHSS. Presentations will be available on memory stick on arrival; this will be provided in English. There will an Exhibition for all those that attend to visit; all refreshments will be served in the Exhibition area.

Conference Venue: Registration Fees:

Novotel Hyderabad Convention Centre Current PHSS Members Become Member by December 2nd 2012 Non-Members : : : Free Admission available (free) INR 17,500

Joining the PHSS:

Madhu Raju Saghee PHSS - India, Director Email: madhuraju@phss.co.uk Mobile: +91 9908020862 Tamsin Marshall PHSS - UK Office Email: info@phss.co.uk Tel: +44 1793 824254

www.phss.co.uk

Other Information:

Confirmation letter will be sent shortly after registration, this must be received prior to arrival. Cancellation of confirmed booking received 10 working days or less, prior to the event will be subject to the full attendance fee. Any substitutes must be informed 48 hours prior to the event by approval of PHSS.

Exhibition and Sponsor Opportunities:

All sponsors will be fully acknowledged by the PHSS chairman at the opening and closing of the Event and within the opening and closing power point slide presentation. For Exhibition Registration and Payment, please contact PHSS Office at info@phss.co.uk or call us on +44 (0) 1793 824254

Indian Exhibition Fee: INR 50,000/-

(PHSS Offers: Banner in Convention Area, One Table Space, Name/Logo in Circulars/Banners, Two Delegates Complimentary)

Evening reception networking dinner for the PHSS Special Interest Group for Education' INR 105,000

Sponsor the Evening reception and networking dinner for the PHSS India Special Interest Group (I-SIG) at the Training course venue the night before the training event starts. The sponsor will be a guest at the reception diner. Your company name/logo and sponsorship acknowledgement will be displayed on all final PHSS event promotional material. Sponsors (1 principal) will be provided with free PHSS membership status for one year.

SOL

Conference Day Refreshments INR 84,500

Sponsor the Conference Day Food & Refreshments and your advertising banner will be on the prime location for viewing in the conference room. Acknowledgement of sponsorship with company logos will be advertised in the course agenda and marketing material for the event. Sponsors (1 principal) will be provided with free PHSS membership status for one year.

Information Sponsor INR 105,000

Information Sponsor will be co-branding on all products provided to delegates, this will include the USB sticks that provide copy of the course presentations (in pdf files) and on, paper for notes and pens used during the course. Sponsors (1 principal) will be provided with free PHSS membership status for one year. Course booking details will be provided in the Course promotion flyer. Program can be changed at the discretion of the PHSS, all changes will be posted on the PHSS website in the event details.

SOL

Program Sponsors: