Risk-Based Validation of cGMP Systems

Richard Poser
Instructor Richard Poser
Product Id 600143
Duration 90 Minutes
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

Risk-Based Validation of cGMP Systems

Overview:
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.

A case study is presented for the construction qualification, relocation and new equipment installation for a cGMP facility. The cost and time savings associated with using risk-based validation will be presented. Over 3,000 systems or pieces of equipment were installed or relocated in a short time frame at a substantially reduced cost. A risk-based approach to validation was employed, dramatically reducing the cost and time for facility qualification.  Comments by regulatory inspectors will be discussed.

Why should you attend:
How much validation is enough?  How much is too much? When should you validate what system? Risk-based validation is the new and FDA-preferred methodology, assuring that sufficient validation is done to meet regulatory and business requirements.

Areas Covered in the Session:

  • Risk-Based Validation
  • Equipment and Utility Qualification
  • Risk management Tools
  • Functional Risk Analysis
  • Risk Scoring
  • Risk Mitigation

Who Will Benefit:This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields and associated vendors such as contract research, manufacturing, testing and systems. The employees who will benefit include:

  • End-users responsible for applications that need to be validated
  • QA managers and personnel
  • Information Technology managers and personnel
  • Validation specialists
  • Engineers
  • Facility staff
Speaker Profile
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.

Sign Up for Our Newsletter