U.S. FDA’s Latest Requirements for the 510(k)
U.S. FDA’s Latest Requirements for the 510(k) Presented by John Lincoln, EAS Independent Consultant. The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process, others are exempt, and some must go through the...
Good Auditing Practices, Making the Most of Your Internal Review
Regular and formal internal audits provide a clear, unbiased view of your facility operations and uncover challenges that must be addressed. No matter your FDA regulated industry, having a formal, thorough and documented audit plan will streamline your audit processes …
The 12-Steps of Operational Efficiency
The 12-Steps of Operational Efficiency How Aligning of Operations and Quality Assurance Can Drive Down Costs While Improving Efficiency. Presented by Mike Hughes and Steve Cammarn, Ph.D., EAS Independent Consultants. Operations and Quality Assurance departments...
FSPCA Preventive Controls for Human Foods, Part 2 of Blended Course
FSPCA Preventive Controls for Human Foods, Part 2 of Blended Course Presented by Omar Oyarzabal, Ph.D. Senior Consultant. This course is for food manufacturers that need to complete Part 2 of the Blended Class on Preventive Control for Human Food. This online class...