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Quality Risk Management Workshop Part 1 of 2
Tuesday, June 26, 2012
8:00 AM to 9:30 AM
Dr. Fritz Erni has a Ph.D. from the Swiss Federal Institute of Technology (Dr. sc.nat. ETH) in Zurich and more than 35 years experience in research, development and quality assurance in the pharmaceutical industry.
He is the Head of External Relations Europe/Japan/CEMAI of Roche. He represents EFPIA on foreign inspections, ICH Q-IWG & on QRM. He received FDAs ‘Leveraging & Collaboration Award’ for developing a web-based knowledge base on QRM used for industry and regulatory. In PDA is chair of RAQAB & PCMO.
Celia N Cruz joined the FDA in August of 2010 as a CMC reviewer in ONDQA. Prior to joining the FDA, Celia led product development, scale up, and technology transfer efforts for multiple products in industry. Celia is a chemical engineer with a PhD from Carnegie Mellon University.
This interactive workshop will give a brief overview of simple quality risk management (QRM) tools. In small groups, participants will work with common QRM tools such as Process Maps, Fishbone Diagrams and Failure Mode Effects Analysis (FMEA) to determine product critical quality attributes and critical process steps for a simple manufacturing process. **Due to workshop format, seating will be limited and will be available on a first come, first served basis. The Pennsylvania Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive at workshops early in order to ensure seating. Please note, as a workshop with interactivity, this event will not be recorded.
Describe how the quality risk management tool can be used to support pharmaceutical development, manufacturing, and Quality by Design approaches
Discuss the product critical quality attributes and critical process steps for a simple manufacturing process.
Audio Synchronized to PowerPoint