Conference Day Two: Tuesday, 29 July 2008

08:30 Registration

09:00 Chairman’s Recap

Dr. Mithilesh Trivedi
Vice President – QA & QC
CALYX CHEMICALS & PHARMACEUTICALS LTD

09:15 Handling Of Product Quality Complaints – A Regulator’s Viewpoint

• Understanding what a regulator such as MOH looks out for during a GMP inspection and what an inspector expects
• Defining what is expected of a pharmaceutical manufacturer in ensuring that a product complies with GMP and regulatory guidelines
• Examining how to manage expectations of your product from a regulator’s perspective
• Highlights of some examples of deficiencies found during GMP inspections

Kadariah Mohd Ali
Principal Assistant Director/ GMP Lead Auditor, Centre for Compliance and Licensing National Pharmaceutical Control Bureau
MINISTRY OF HEALTH MALAYSIA

10:15 How Do You Stay One Step Ahead Of GMP Auditors: Tips To Be Prepared For Audit Checks

• How GMP audit has evolved in response to today’s new regulatory guidelines
• Tips to ensure your daily documentation process keeps you prepared for surprise checks
• What do you do during a surprise GMP audit to ensure your operational processes are not disrupted?
• Tips & ideas on how to document your processes diligently and be ready for audit checks anytime
• Case studies and examples from Asia, Europe & U.S.

Moderator:

Doug Rufino
Senior Director
QUALITY CONTROL AND ANALYTICAL DEVELOPMENT

Panellists:

Regina Yeo Director of Quality, Asia Pacific GLAXOSMITHKLINE	Darren Freestone Senior Consultant SEERPHARMA (SINGAPORE) PTE LTD
Liza B. Ordinio Regulatory Affairs and Quality Assurance Manager HI-EISAI PHARMACEUTICAL INC.	Dr. Klaus Pittertschatscher Head of Quality Assurance Corporate Q.P. PAA LABORATORIES

11:15 How To Ensure All Levels Of Personnel In Your Company Interpret GMP Compliance Effectively

• Tips to communicate to your team on expectations versus what needs to be complied with
• How to encourage your QA/QC team to work in synergy with your process engineers/ IT team
• Best practices of how to translate the GMP guidelines into operational excellence across the entire team for maximum business results

Darren Freestone
Senior Consultant
SEERPHARMA (SINGAPORE) PTE LTD

12:00 GMP Challenges In Production Of Excipients Used For Advanced Therapies

This presentation will take you through the new or drafted legislation and guidelines on excipients in the EU and U.S. The implications of legislation regulating the advanced therapies (Tissue Engineering, Cell Therapy and Gene Therapy) on the production of excipients and the risk based approach using different cell culture materials to grow the cells used in advanced therapies will be outlined. Dr. Klaus will also share with you the rapid and successful implementation of quality systems and the pitfalls in production and quality control of excipients, including the issues and opportunities of animal derived material in cultivation. Other issues which will be covered include:

• Understanding the implications of legislation in the EU and U.S. on the production of excipients
• New draft directive on excipients (EU)
• Background on advanced therapies (Tissue Engineering, Cell Therapy and Gene Therapy)
• Risk-Based approach using animal derived excipients
• Holistic implementation of quality systems in production of excipients

Dr. Klaus Pittertschatscher
Head of Quality Assurance Corporate Q.P.
PAA LABORATORIES

13:45 Use Of Crystal-Ball To Control Variability Under GMP

• How to predict the likelihood of uncertainty in the product design
• Tips on identifying potential failure modes and quantifying their effect on product quality
• Understanding how variable or uncertain input would affect product quality and performance

Barry Gujral
Coordinator, Process Analytical Technology
DSM PHARMACEUTICALS INC

14:30 Overcoming The Challenge Of Differing Interpretations Of GMP In Different Locales

• An overview of different regulatory guidelines and their implications on your business
• Interpretation by regulatory authorities
• How do auditors interpret GMP?
• Tips and techniques on how to address the differing interpretations of GMP to meet your business needs

Dr. Mithilesh Trivedi
Vice President – QA & QC
CALYX CHEMICALS & PHARMACEUTICALS LTD

A final chance for you to exchange business cards and ideas

15:30 Risk-Based Approach For Quality System: Auditing And Qualification

• Basic understanding / overview of risk assessment process and its application to competitive business environment
• Reckitt Benckiser’s approach on risk assessment: How it is done for suppliers/ vendors for raw materials, packaging materials and equipments/instruments
• Performing risk-based audits of contract manufacturer and self manufacturing (internal audit)
• Performing product and process risk assessment with emphasis on micro risk assessment
• Tips and techniques of developing validation or audit plan based on risk assessment
• Benefits of risk-based approach

Syed F. Huda Quality Manager RECKITT BENCKISER PAKISTAN

Irfan Ali Zeb Quality Assurance Manager RECKITT BENCKISER PAKISTAN

16:15 Special Interactive Round Table Session: Overcoming U.S. FDA Regulatory Hurdles In The Manufacturing Of Drugs From Botanical Sources

Based on several practical examples, Isaac will be discussing ways of overcoming the challenges in complying with FDA and regulatory guidelines with you in this unique round table session which includes interactive exercises. Come with your most pressing questions and Isaac will take you through the following:

• A brief overview of FDA guidelines and its implications on your business
• Tips and strategies to interpret U.S. FDA requirements accurately
• Techniques to ensure your products meet the minimum standards
• Pitfalls to avoid

Discussions facilitated by:

Isaac Cohen
Chairman and CEO
BIONOVO INC.

17:30 GMP Challenges Concerning Microbiological Quality Control And Quality Assurance

The presentation will cover the present efforts taken to harmonise compendial requirements for microbiological quality control of medicinal products in the European Pharmacopoeia, the United States Pharmacopoeia and the Japanese Pharmacopoeia.

• Examining the current status and updates of regulatory guidelines
• Understanding the timelines for the implementation of the new requirements
• A detailed comparison between the requirements to date in the EP and USP and the new, harmonised requirements to come into action in 2009
• Techniques on how to validate the new methods for implementation

Christine Magin
Manager Quality
KWIZDA PHARMA GESMBH

18:00 Closing Remarks By Chairman

[ Register Now] · [ Next: Workshops: Wednesday 30 July 2008 ]