Applied QbD hybrid approach: 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 fast track virtual bio-therapeutic company?s late phase II product, ? How do we deliver a Process Validation in most expeditious manner that gets us approved (Fast Track)? ? Where, when and how do we get started? ? How much will our process validation cost? What Attendees will Learn: ? How to apply a Hybrid QBD approach to Pre and clinical data to develop a robust Process Characterization ? How to set up for an efficient and effective Process Validation to drive best possible market introduction timelines ? How to develop a process development ?roadmap? for use in subsequent product developments

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.