Training Requirements and Practices to Assure QSR and ISO Compliance
  • CODE : JEKA-0035
  • Duration : 60 Minutes
  • Level : Intermediate
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Jeff Kasoff, RAC, CMQ/OE has more than 30 years of experience 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 start-up 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 the primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff received his Regulatory Affairs Certification from RAPS, his Manager of Quality and Organizational Excellence certification from ASQ, and his Lean Black Belt from IIE. He is also a certified internal auditor for MDSAP, ISO 13485:2016, and EU MDR, from Exemplar Global.

A complete and effective employee training program must be in place to assure training requirements are established, implemented, and verified. This session will instruct attendees on the regulatory requirements of personnel training, and the establishment of a the training program, including new employee training, methods of training, how to document training so that it is readily available for review (by managers, auditors, or inspectors).

Areas Covered

  • Regulatory requirements of personnel training
  • Establishment of a training program, including new employee training
  • Methods of training
  • The importance of the legal manufacturer and understanding what this is
  • How to document training for making it readily available for review
  • When to evaluate training requirements, training effectiveness, and when training is not required

Course Level - Intermediate

Who Should Attend

  • Training Departments
  • QA managers and Personnel
  • Regulatory Affairs
  • Human resources (HR) managers and staff
  • Documentation department
  • Consultants

Why Should You Attend

A large quantity of a product and/or process nonconformities can have a significant impact on your product, as well as your company’s survival. A very high percentage of nonconformities are caused by an inadequate training program. To satisfy QSR and ISO 13485 requirements as well as produce quality products, companies must assure personnel is trained on their routine job practices as well as familiar with requirements that impact them.

  • $179.00



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