ICH Q11: Development and Manufacture of Drug Substances Status, Challenges, and Expectations

ICH Q11 has been an industry hot topic for years, and now the guideline has reached the consultation phase. In this recording, captured at ISPE's 2011 Washington Conference, ICH Expert Working Panel member Betsy Fritschel gives you an insider's perspective on ICH Q11. Get a brief history of ICH and how Q11 evolved, delve into the specific content of the document, and learn how you can participate in the consultation phase and provide your comments to the ICH.

Betsy P. Fritschel
Director
J&J Corporate

Betsy Fritschel is Director of Quality & Compliance at Johnson & Johnson. She joined Johnson & Johnson in 1981 as an analytical chemist and has held positions of increasing responsibility in quality and API manufacturing since then. She holds a BS in chemistry and has extensive experience in API manufacturing. She is a member of the WHO Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations. She is the past chair of the PhRMA API Technical Group. She was a member of the Expert Working Group for the International Conference of Harmonization (ICH) Q7A Active Pharmaceutical Ingredient Good Manufacturing Practices. She has published and lectured both in the US and internationally on GMPs for Active Pharmaceutical Ingredients.

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