Event Detail
Change Control Management for a Stability Program – Potential Changes and Minimizing the Impact of Registration
February 2, 2010
- Live Webinar CANADA
BenAstrum
Live Web Training Course Tuesday, February 2, 2010 (1:20 p.m. – 3:45 p.m. EST) (12:20 p.m. – 2:45 p.m. CST) (10:20 a.m. – 12:45 p.m. PST) Instructor: Kim Huynh-Ba Discussion Points: * Why Stability is defined as a critical quality attribute * What type of CMC changes in the life cycle of a drug product * How changes affect the stability profile of the product throughout the expiry * Distinguish between minor and major changes of a registration stability program * Determine potential risks to manage these stability changes