The training provides insight into what is required to implement an effective software validation process for product software. Then explore what is required for software validation that is integral to automated business processes. Finally understand the software validation process that is required for the control of documents and records. It is clear that the medical device industry is moving to implementing more software and automated processes as essential parts of products and business practices.
Why you should Attend
The importance of an effective software validation process in today's reliance on software for both integral to products, business processes and required FDA documents/records.
Areas Covered in the Session
- The medical device industry is one of the leading regulated industries that takes software validation seriously.
- FDA requirements are different for automated process than for medical devices
- Having to implement software validation processes and then have to explain reasons why to FDA is no way to conduct business; way to costly
Who Will Benefit
- Managers and 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.