Implementing a periodic validation review program: A case study

4^th International Conference on Pharmaceutical Regulatory Affairs

September 08-10, 2014 DoubleTree by Hilton Hotel Raleigh-Brownstone-University, USA

Charles Stock

Scientific Tracks Abstracts: Pharmaceut Reg Affairs

Abstract :

Problem Statement: For a multi facility and site sterile products manufacturer, ? Regulatory Agencies require us to have a Periodic Validation Review Program ? What does ?periodic? mean? ? How to develop a defendable rationale behind the actual program ? How do we get started and maintain it without draining our resources What Attendees will Learn: Develop an understanding of how to, ? Define this program to align with Regulatory expectations ? Align this program with the new FDA Process Validation requirements and current owner validation programs ? Leverage existing review programs like environmental monitoring, annual product reviews, product trending reports, maintenance and calibration reports to reduce redundancy

Biography :

Charles Stock offers more than 34 years of technical, compliance and process/operations experience in the technical manufacturing industries. He has relevant experience with facility and equipment start-up, commissioning and qualification, operations management, project management, product development, process development and transfer, training and compliance. His operations and compliance expertise encompasses facility start-up, manufacturing process analysis and streamlining, facility turnover and commissioning, operations training/staff management and logistics planning. He has also developed and presented training programs for C&Q project planning, Quality Systems, topics on leaning out capital projects, development of operating strategies and performing risk assessments. His operations and start up experience encompasses medical device, biotechnology, aseptic/sterile, OSD, and specialty dosage form facilities.