To start the conference, the first keynote speaker, CDER Director Dr. Janet Woodcock, gave an interesting talk “Vision for Quality in the 21st Century.” Topics she addressed in her presentation included:
- What is the desired state, and have we achieved it?
- The 2 faces of Quality in 2012
- CDER’s progress
- 21 CFR 211.100(a) and Quality by Design (QbD)
- What has QbD delivered thus far?
- Additional opportunities for QbD
- FDA efforts in international collaboration
- Status of progress towards the desired state
- Industry Quality Systems
- Root causes of failures
- Quality Management of regulation
Other noteworthy talks during this excellent 2-day event included:
“Future Vision for the Office of Compliance,” by Ilisa Bernstein, FDA/CDER’s Acting Director of the Office of Compliance
“Culture of Quality,” by Mary Oates, Pfizer’s VP of Global Quality Operations
“International Regulatory Perspective,” by Gerald Heddell, Director of Inspection, Enforcement, and Standards for the UK’s Medicines and Healthcare Regulatory Agency (MHRA)
Still to come is a “meet the press” forum, and BioQuality will be there.
BioQuality subscribers will get summaries and analyses of these talks in upcoming issues. To subscribe: www.bioquality.biz