Sponsors and manufacturers must take sole responsibility for managing the risks associated with their products in a way that ensures protection of patients, integrity of supplies, minimizing drug shortages, and optimizing continuous quality improvement.
Quality issues and compliance violations can occur at any point in the supply chain and put product production at risk. As the complexity of product development and globalization of supply increases, there are even greater risks. Gaps or weaknesses in the management of quality can have a profound impact on drug shortages and company integrity.
Quality Risk Management (QRM) is a set of tools that a company can implement to ensure adequate selection, qualification, and oversight of vendors, thorough investigation of out-of-specification (OOS) results and product complaints to determine and mitigate the root cause of a risk, and effective evaluation of changes.
This Huddle seminar will review the foundations of Good Manufacturing Practices, including acceptable differences between GMP requirements for early and later stage clinical development. This conference will also review Quality Risk Management for effective and efficient GMP operations and continuous quality improvement. ICH 8, 9, and 10 will be covered.
Peggy J. Berry, BS, MBA has over 30 years of experience within regulatory affairs and drug development. During her career, she has been involved in submission of over 500 submissions to the FDA, EU, Japan, Canada, Australia, and the Middle East. She has had direct responsibility for managing submission, negotiation, and maintenance for approximately 100 INDs, 50 CTAs, 25 NDAs, 20 ANDAs, 3 BLAs, and many more. During this time, she has led teams to prepare for and participating in more than 200 meetings with regulatory agencies worldwide; including directly conducting over 150 FDA meetings (Pre-IND through Pre-NDA/BLA), 10 EU meetings (EMA and local), 5 Canadian, 2 Australia/New Zealand, 3 Japan, and 3 Middle East (Jordan and Lebanon). These meetings &submissions have involved both drugs and biologics across a number of therapeutic areas, including primarily respiratory, allergy and immunology, oncology, cardiovascular, dermatology, metabolic disorders, ophthalmic, and CNS.
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