9:00AM – 10:00AM
KEYNOTE SESSION: “Ten Commandments” — The Keys to a Seamless Technology Transfer
Adnan Sabir, Principal Consultant, Pharma Consulting Services, Former Associate Director of QA, KOWA PHARMACEUTICALS
A seamless technology transfer is desired by all but difficult to achieve in most cases due to poor planning. Set the tone for the next two days with these “ten commandments” that should aid in preparing a successful tech transfer plan.
- Determine a plan for what should ensure a successful tech transfer using ten key rules
- Discuss the trio of ICH guidelines Q8, 9, and 10, with an emphasis on risk analysis to build quality into a product
- Increase confidence for releasing a product commercially: Explore the benefits to optimization/scale-up
- Understand the risk of miscommunication with CDMOs