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Washington Marriott Hotel

Apr 15, 2013 8:30 AM - Apr 17, 2013 12:00 PM

1221 22nd Street NW, , Washington, DC 20037-1294 , USA

CMC Workshop: From Drug Development to Global Supply to Patients

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Session 10B: Process Validation: Maintaining the State of Validation in the Continuous Improvement Paradigm

Session Chair(s)

Prabu Nambiar, PhD, MBA, RAC

Principal

Syner-G Pharma, United States

Continuous improvement (CI) is one of the key benefits of drug development under the QbD based drug development paradigm. The traditional process validation requirements might be interpreted to be limiting in terms of the industry’s ability to realize the full benefits of the CI process. In this regard, FDA and EMA have issued a draft process validation guidance document that provide for the possibility of continuous process verification (CPV) to cover an alternative approach to process validation based on a continuous monitoring of manufacturing performance. The FDA draft guidance has focused on process validation as a three stage process – Process Design, Process Qualification and Continuous Process Verification. The objective of this session is to explore how companies can use the CPV approach to maintain the state of validation and be in full compliance with regulatory requirements.

Speaker(s)

Continuous Improvement and Continuous Process Verification: FDA Perspectives

Kelli F. Dobilas

FDA, United States

Supervisory Investigator, NWJ-DO, ORA

Maintaining the State of Validation in an Outsourced Manufacturing Paradigm

Eda Ross Montgomery, PhD

Shire Pharmaceuticals, United States

Senior Director

T. Venkateshwaran, PhD

Innovative Approaches To Process Validation

T. Venkateshwaran, PhD

Merck & Co., Inc., United States

Vice President and Global Head CMC Biologics, Medical Devices and Comb

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