Seamless Technology Transfer Process (TTP) to CMOs
Journal of Developing Drugs

Journal of Developing Drugs
Open Access

ISSN: 2329-6631

+44 20 3868 9735

Seamless Technology Transfer Process (TTP) to CMOs

International Conference and Expo on Generic Drug Market & Contract Manufacturing

November 07-09, 2016 Barcelona, Spain

Adnan Sabir

Pharma Consulting Services, USA

Scientific Tracks Abstracts: J Develop Drugs

Abstract :

Transferring the â??Risk Basedâ??, ICH Q9 compliant, drug development and manufacture to CMOs can be subject to many pitfalls. I would like to share my experience of how we can make such Technology Transfer Process (TTP) effective, seamless and utilizing the latest regulatory, technical, practical and business tools. Considerations for preparing for the process transfer, ensuring logistics, quality based design principles, equipment and materials consistency, and posttransfer activities will be discussed; which are very crucial to the success. Key learning objectives will include: Understand the product transfer process from preparing the transfer, performing the transfer and what is required after the transfer; establish and review metrics (measurement/feedback tools) to determine product transfer success; and establish a solid Technical Quality Agreement (TQA).

Biography :

Adnan Sabir is currently employed by Kowa Pharmaceuticals of America, leading QA CMC activities. Previously, he was a Principal Consultant and Founder of his Business Pharma Consulting Services, Inc. He has more than 30 years of hands-on and management experience and a proven track record for formulation and process development for brand and generic products approved by FDA and other agencies globally. He served as VP of Process Development and Optimization Group at Dr. Reddy’s Lab during 2009-2012. He has also worked extensively as a Consultant providing solutions for the regulatory issues, implementation of QbD/ PAT, and risk based development of products to many life science customers. He has significant knowledge in CMC, cGMP, 21 CFR Part 11 and ICH guidelines, serialization and FDA regulations. He is also Invited Speaker at various forums in United States and other countries globally.

Email: [email protected]