Speaker Profile

Richard Poser

President, First Quality Inc

Richard Poser, PhD is President of First Quality Inc., a quality consulting firm focused on Quality Systems, Training and Validation. Their clients include biotechnology, pharmaceutical and medical device manufacturers, as well as the vendors such as contract laboratories, instrument manufacturers, contract manufacturing sites and software developers that support these highly regulated industries. Following an academic career in drug metabolism and chemotherapy, Dr. Poser was Director of Analytical Sciences and later Director of Information Systems at the Fisons Pharmaceuticals site in Rochester, NY. He joined Dura Pharmaceuticals in San Diego as Analytical Laboratory Director and Director of R&D Quality Assurance. Following acquisition of Dura by Elan, Rich was appointed Director of Quality Laboratory Operations and led their 21CFR Part 11 training and audit team. Now in private practice as a quality consultant, he also lectures at UCSD Extension in validation and has presented or chaired public seminars on cGMP Requirements, Computer System Validation, Vendor Qualification Auditing, Analytical Methods Validation and Infrastructure Qualification.




Speakers
  •   Recorded
  •   View Anytime
  •     ¤10.00
Risk-Based Validation of cGMP Systems

This presentation will review a methodology for implementing Risk-Based Validation of test equipment, facilities and analytical instruments used in GLP, cGMP and GCP facilities.

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Speakers
  •   Recorded
  •   View Anytime
  •     ¤10.00
Risk-Based Validation for GxP Facilities

This presentation teaches a practical methodology for creating and applying Risk-Based Equipment Validation. It shows an example of how this process may be integrated into a facility Master Validation Plan.

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