Welcome to the 3rd Annual ISPE-FDA CGMP Conference. The FDA and Industry experts will provide you with the insights you need to ensure quality both day-to-day and strategically, over the product lifecycle. No other event drives critical conversations forward like this annual conference. We are excited you are joining us for these vital discussions. During this content-filled three days, you will have the unique opportunity to interact directly with Industry and FDA representatives.
Dr. Janet Woodcock, Director, CDER, FDA - Bringing Manufacturing, Science and Quality to the Next Level
Mary Oates, PhD, VP, Global Quality Operations, Pfizer - Implementing and Measuring a Culture of Quality
David Smith, Executive Vice President, Global Operations and IS, AstraZeneca - Approaches in Ensuring Reliable Supply from India
With increasing complexity of supply chains and the need to rapidly respond to internal and external demands, we must remain committed to using sound science and risk-based approaches to ensure control. The joint FDA-ISPE program committee has worked hard to assure that you will return to your company equipped with the tools for robust end-to-end controlof your processes in the areas that matter the most: Breakthrough Therapy, Knowledge Management, Tech Transfer, Combo Products, Assessing Blend and Content Uniformity, Process Validation, Data Integrity and Drug Shortages.
Monday , 2 June 2014
08.00 – 09.15
Quality Systems: Lifecycle from Development to Discontinuation (Holiday 1-3 Ballroom)
Welcome and Opening Remarks
Implementing and Measuring a Culture of Quality, Mary Oates, PhD
Bringing Manufacturing, Science and Quality to the Next Level, Janet Woodcock, MD
Following an unprecedented two years in which the pharmaceutical industry has faced numerous challenges posed by the global pandemic, pharmaceutical manufacturing has had to react and respond to meet the rapidly changing requirements and timelines. This has necessitated a radical rethink in how we...
Continuous manufacturing (CM) is gaining traction in pharmaceutical manufacturing. The purpose of this post is to highlight some of the differences between small molecule Drug Substance (DS) and Drug Product (DP) continuous manufacturing (CM), which may be helpful in considering the development and...
Gaelle Saint-Louis is the Women in Pharma® (WIP) Chair of the ISPE San Diego Chapter. She began her involvement with ISPE as the Young Professional (now Emerging Leaders) Chair for the Greater Los Angeles Chapter in 2019. After relocating to San Diego, she took on a leadership role within the...