The training prepares the company to provide FDA with the evidence they are requesting and avoids raising issues that are not being asked for. The FDA inspection is being conducted to assess the effectiveness of the companies Quality Management System and the FDA regulations such as Medical Device Reporting, Corrections and Removals, Labeling, Premarket Notifications, Electronic Records and Signatures, to name a few. The training is intended to provide you with expectations that should prevent you from being overwhelmed or surprised by the FDA inspection.
Why you should Attend
The training prepares the company to provide FDA with the evidence they are requesting and avoids raising issues that are not being asked for.
Areas Covered in the Session
- The FDA inspection is being conducted to assess the effectiveness of the companies
- Quality Management System
- The FDA regulations such as Medical Device Reporting
- Corrections and Removals
- Premarket Notifications
- Electronic Records and Signatures
- To name a few
Who Will Benefit
- Quality Personnel
Raymond M. Pizinger has over 30 years of hands-on professional experience in the fields of Best Business Practices, Quality Systems, Worldwide Regulatory Compliance and Submission, Quality Assurance, Engineering, Operation. Directed quality organizations through start-up, mergers, acquisitions, divestitures, IPO’s and OEM alliances. He has an extensive experience in the Medical Device Industry as an executive, consultant and international trainer.
Provides leadership, guidance and oversight to all plants within the worldwide business to ensure consistency of Quality programs, policies, funding and procedures and to ensure maintenance of an outstanding level of global Regulatory compliance.
Has helped many companies prepare for FDA inspections as well as helped companies that didn't prepare and had to respond to FDA with corrective action plans that would resolve the FDA observations raised during the inspection. The later is much more difficult than good preparation.