Upon completion of this training program, attendees will learn key elements of a change management process, identify key indicators of change and learn the regulatory requirements for change control. This session will also discuss different observations due to the lack of effective change control program.
Why Should You Attend:
Stability is defined as a critical quality attribute (CQA) in the drug development process as it determines the shelf life of a pharmaceutical product; however, change is an inherent part of the product life cycle. Change can be made as an addition, deletion or modification of process, materials, product, procedures, equipment, and these changes may result to adding, canceling, amending or modifying current stability studies.
Who Will Benefit:
Quality control managers and personnel
Manufacturers of raw material and ingredients
QC analysts and lab managers
QA managers and personnel
Kim Huynh-Ba has over 25 years of experience in analytical development, project management, strategic drug development and stability sciences. She is currently the executive director of Pharmalytik, where she provides consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree on harmonization and optimization of analytical best practices since 2003.
Use coupon code NB5SQH8N and get 10% off on registration, Valid till Dec 31st 2015.