This Risk-Based Validation training for cGMP Systems will guide you through case studies for the construction qualification, relocation and new equipment installation for a cGMP facility.
Fact:
How much validation is enough? How much is too much? When should you validate what system? Risk-based validation is the new and preferred methodology, assuring that sufficient validation is done to meet regulatory and business requirements.
A case study is presented for the construction qualification, relocation and new equipment installation for a cGMP facility. Over 3,000 systems or pieces of equipment were installed or relocated. A risk-based approach to validation was employed, dramatically reducing the cost and time for facility qualification. Comments by regulatory inspectors will be discussed.
Areas Covered in the seminar:
- Risk-Based Validation.
- Equipment and Utility Qualification.
- Risk management Tools.
- Functional Risk Analysis.
- Risk Scoring.
- Risk Mitigation.
- Score-Based Validation.
- Project Outcomes.
Who will benefit:
This webinar will provide valuable assistance to all regulated companies that need to validate qualify or their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. 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
Instructor Profile:
Rich Poser, 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.
Dr. Poser was Director of Analytical Sciences and later Director of Information Systems at the Fisons Pharmaceuticals site in Rochester, NY. Following work in product development, laboratory automation, and validation and quality systems for the Mylan Pharmaceutical Company, Rich joined Dura Pharmaceuticals in San Diego as Analytical Laboratory Director and Director of R&D Quality Assurance. After the acquisition of Dura by Élan, 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, cGMP Regulations and analytical methods validation, and has presented or chaired public seminars on cGMP Requirements, Computer System Validation,
Vendor Qualification Auditing, Analytical Methods Validation and Infrastructure Qualification.
