Employee Competence, Awareness, and Training: Current Trends in Regulatory Compliance and Industry Best Practices
1 Hour and 30 Minute Video | Thomas Myers, Zimmer
Medical device regulators require industry manufacturers to ensure that employees are not only qualified for a given position, but also that the company has provided the necessary job specific training and documentation. One of the biggest challenges faced by manufacturers is demonstrating that employees are fully aware of how the product is used and the impacts that product defects may have on product performance and safety. In order to successfully complete a regulatory inspection, device quality professionals must provide objective evidence and documentation illustrating determined competency and employee evaluations.
- Methods for exhibiting employee training and competence
- Comparison of ISO 13485 and FDA QSR requirements and interpretations
- FDA examination phases and expectations
- Case study insight and best practices
Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
- Quality Systems
- Quality Management
- Training Management
Quality Systems Solutions Director – Global Quality Systems
Thomas Myers currently holds the position of Quality Systems Solutions Director within the Global Corporate Quality Systems group at Zimmer, Inc. a ~$5 billion annual revenue orthopedics manufacturer based in Warsaw, Indiana.
Prior to joining Zimmer, Tom has served in a QA/RA Directorship capacity spanning much of his 22+ years in the Medical Device and Diagnostic Industry, which such notable companies as Philips Healthcare, C.R. Bard, Boston Scientific, W.L. Gore & Associates, and Terumo Medical.
Decision Criteria: New FDA Guidance Impacting the Requirement for 510(K) Clearance of Modified Devices
1 Hour Video | Kelliann Payne, Hogan Lovells
1 Hour Video | Jennifer Geettert and Lisa Schmitz Mazur, McDermott Will & Emery