Vendor Qualification Auditing for FDA Computer System Compliance

Why Should You Attend:

This webinar will explain and illustrate inspection and auditing of vendors who provide software used to support GXP manufacturing and testing, through audit forms, processes and checklists. We will explore how vendor qualification audits may be used in the vendor selection process. Case studies and redacted audit reports will be used throughout the presentation.

We will show how audit findings of competitive vendors may be used to select products and negotiate pricing and terms. We will examine the audit process from initial request to conduct an audit through the conduct of on site inspection, closing meetings and audit reports.

Illustrations of observations and remediation plans will be used throughout. The various types of audits will be discussed, including initial qualification, remediation, routine, for cause and correspondence. The seminar will include sample forms and checklists which may be used by the participants, along with some initial training on the appropriate use of forms and checklists.

Areas Covered in the seminar:

• Audit types.
• Pre-audit materials.
• Conducting site inspections.
• Closing meetings.
• Writing audit observations, recommendations and remediation.
• Use of audits in vendor qualification and selection.

Who will benefit:

This webinar will provide valuable assistance to all regulated companies that need to prepare for inspection of the facilities, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. Contract facilities providing clinical, laboratory and data systems will also benefit.

The employees who will benefit include:

• End-users responsible for testing
• QA managers and validation personnel
• Information systems managers and personnel
• Senior Quality, Facilities and R&D Management
• Regulatory Affairs staff
• Quality system auditors

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 and symposia.