The training provides insight into FDA requirements for an effective complaint system, which includes a medical device reporting system.
In addition, this course will explore easy methods of implementing trend analysis while meeting FDA's documentation requirements for complaint records. Also for new companies, you'll see why it might be better to start simple before implementing a costly automated complaint reporting system.
Why you should Attend
The importance of an effective complaint and medical device reporting (MDR) system in today's medical device industry is essential to preventing unnecessary product and regulatory problems that can cost multiple times the cost of an effective system.
Areas Covered in the Session
- The medical device industry is one of the leading regulated industries that takes customer service and complaint reporting seriously
- FDA requirements are somewhat prescriptive and helps create a systematic approach
- Having to implement complaint reporting system and medical device reporting system and then have to explain reasons why to FDA is no way to conduct business; way to costly
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.