FDA and ISO Compliance Personnel Training - 2017

To satisfy QSR and ISO 13485 requirements as well as produce quality products, companies must assure personnel are trained on their routine job practices as well as familiar with requirements that impact them. A complete and effective employee training program must be in place to assure this. This session will instruct attendees on the regulatory requirements of personnel training, and establishment of a training program, including new employee training, methods of training, how to verify training effectiveness, and how to document training so that it is readily available for review (by managers, auditors or inspectors).

Areas Covered in the Session:

Regulatory requirements for personnel training
Establishment of a training program
New employee training
Methods of training
Making training records "readily available for review"
Evaluation of training requirements
Verification of training effectiveness
When is training not required?

Who Will Benefit:

Personnel who perform training
Personnel who receive training
Low-mid level management
Regulatory Affairs personnel
Human resources (HR) staff

Speaker and Presenter Information

Jeff Kasoff, RAC, CMQ/OE has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies.