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Process Validation Seminar

June 20, 2014
08:30 AM to 04:00 PM EST

The FDA has made significant progress in implementing the concepts of "Quality by Design" (QbD) into pre-market processes. The QbD concept is that quality should be built into a product through a deep understanding of the product, both how it's developed and how it's manufactured. A comprehensive understanding of the risks involved in manufacturing a product and how best to mitigate those risks is also required.

The QbD initiative attempts to provide guidance on pharmaceutical development to facilitate design of products and processes with maximum efficacy, safety profile and product manufacturability. QbD forms the basis of process validation activities conducted by pharmaceutical manufacturers in validating their product manufacturing processes.

Join us on June 20, 2014 for a review of "Quality by Design" concepts and a discussion on its relevance to process validation. During our discussion we will have an opportunity to see a demonstration of Validator, a software product that facilitates the adherence to the QbD principles and best practices in process validation.


8:30 to 9:00 Breakfast

9:00 to 10:30 Quality by Design

10:30 to 10:45 Break and Networking

10:45 to 12:00 Process Validation

12:00 to 1:00 Lunch and Discussion

1:00 to 2:00 Case Study

2:00 to 3:30 Validator PV

3:30 to 4:00 Question period

About the speaker

James Desai is a pharmaceutical industry professional with extensive experience in compliance, quality, operations and I.S. He is currently the Chief Compliance Officer and Director of R&D at Oregon Freeze Dry, Medical Devices and Pharma Division. Past roles have included leadership positions in pharma and biotech Quality Assurance, Operations and Information Services for NPS Pharmaceuticals, Innopharm Inc., Hemosol and TorPharm.

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