Each drug product may be unique due to different components, and this is a known fact. The chemical and physical properties of active pharmaceutical Ingredients (APIs), manufacturing methods and procedures, the excipients, formulations, storage conditions, containers and closers and the stability of the product, etc. make them all the more unique. In pharmaceutical industry, we are required to establish requirements for the expiration and stability on a drug product. The requirements are to assure that the date is appropriate as required by the current good manufacturing practice (CGMP) for finished pharmaceuticals.
This conference by expert speaker Dr. David Lim, Ph.D., RAC, ASQ-CQA, is intended to discuss regulatory requirements and good practices to establish a product stability program. In particular, you will know how to present FDA-compliant practices in adequately implementing regulatory requirements for expiration dating and stability testing program depending upon product types.
Within 60 minutes, you will know why should firms consider and implement the good practices, and remain compliant to recommendations of FDA, so that they can avoid FDA enforcement actions proactively with much awareness. Join the session to know the current view and perspectives of FDA on the product stability testing program.
Why Should You Attend:
This product stability testing webinar will explain, in detail, the requirements of the FDA’s drug stability guidelines that are stipulated for drug products and how to design a product stability testing plan that can be applied to new or modified products in the pharmaceutical, biotechnology and medical device industries.
You will also get answers to the following tough questions:
Who Should Attend
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.