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In November 2019, the International Council for Harmonization (ICH) Q12 guideline entitled Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management was finalized. Specifically, ICH Q12 provides a framework to facilitate management of post-approval Chemistry, Manufacturing and Controls (CMC)changes (manufacturing, packaging, microbiological and analytical test methods) in a more predictable and efficient manner. In addition, the guideline addresses the gaps for the implementation and application of ICH Q8, Q9, Q10 and Q11 for the global harmonization of post-approval changes. Furthermore, the ICH Q12 harmonized approach for technical and regulatory considerations for lifecycle management promotes innovation and continual improvement.

This webinar will provide an overview of the guideline and will explain the Established Conditions (EC) discussed therein, as well as the applicable regulatory requirements. A deep dive into Post Approval Change Management Protocols (PACMP) and Product Lifecycle Management (PLCM) as tools to manage change will also be discussed.

This webinar will appeal to all technical, quality operations and regulatory personnel in drug or combination product development and commercialization.

Dr. Donald Klein

Donald Klein

DLK Consulting Services, Inc.

Dr. Klein is a regulatory, scientific CMC Expert with 23 years (1995 – 2017) of experience as a Senior Review Chemist of new drugs in CDER/FDA where he received upon retirement the FDA Distinguished Career Service Award (2017) from the FDA Commissioner. While at the FDA, Don significantly contributed to developing FDA policies for pharmaceutical packaging, comparability protocols, and drug master files. With respect to post-approval changes, his last 12 years were dedicated to the CDER CMC post-marketing division. In addition, Don worked with fellow FDA experts and Industry to resolve drug shortage issues from 2005 to 2017. Prior to starting a Consulting Company (7/2019) with his wife Lynda Taskett, Dr. Klein was a CMC Consultant at parexel (9/2017 – 6/2019). In his professional career he has either reviewed or drafted applications in the following therapeutic areas: Oncology, AIDs, Neurology, Psychiatric, Metabolic/Endocrine, Dermatology, Pulmonary, Analgesic, Radiopharmaceutical; and OTC. Don has been an invited speaker at AAPS, PDA, and RAPS Conferences and had presented several seminars (1999 – 2017) within the FDA. He received a B.S. in Chemistry from Allegheny College (1982) and a Ph.D. in Synthetic Organic Chemistry from Emory University (1988).
Fran DeGrazio

Fran DeGrazio

Chief Scientific Officer

Fran DeGrazio has 35+ years of experience in the pharmaceutical packaging and delivery industry with extensive expertise in injectable drug products, including vial container closure systems and prefillable systems for combination products. Fran has held numerous technical roles at West, including R&D, Quality & Regulatory, Technical Customer Support, Analytical Laboratories and Scientific Affairs. In her current role as Chief Scientific Officer she is responsible to leverage scientific and regulatory understanding across the enterprise. Fran received the Philadelphia Business Journal 2018 Healthcare Innovators of the Greater Philadelphia Region Award and the Healthcare Business Woman’s Association Luminary Award for West in 2017.