iSpeak Blog

Day 1 of the 3rd Annual ISPE-FDA CGMP Conference


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

Oates & WoodcockDSmith

 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 control of 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
09.15 – 10.20 General Session: Metrics Implementation Overview
10.20 – 11.00 Networking Break (Foyer)
11.00 – 12.00 Metrics Implementation Panel Discussion (Holiday 1-3 Ballroom)
12.00 – 13.00 Lunch (Exhibit Hall, Holiday Ballroom 4-6)
13.00 – 14.15 Breakout Sessions:
  Track 1 Track 2
  Tech Transfer (Holiday Ballroom 1-3) Combo Products: How GMPs Work Together From Device And Drug Product (Peale)
14.15 – 15.00 Networking Break (Exhibit Hall, Holiday Ballroom 4-6)
15.00 – 16.30 Knowledge Management (Holiday Ballroom 1-3) ISPE’s Stratified Sampling White Paper: Assessing Blend And Content Uniformity (Peale)
16.30 – 17.30 Breakthrough Therapy (Peale) Process Validation (Holiday Ballroom 1-3)
17.30 – 19.00 Networking Reception (Exhibit Hall, Holiday Ballroom 4-6)
19.00 – 20.30 Night Session: Process Validation (Peale)