Jeff Kasoff, RAC, CMQ/OE, Lean Black Belt, 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 unique Read more
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 training program, including new employee training, methods of training, and how to document training so that it is readily available for review (by managers, auditors, or inspectors).
Why Should You Attend:
A large quantity of 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 ensure personnel are trained on their routine job practices as well as familiar with requirements that impact them.
Course Outline:
• 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 to make it readily available for review?
• When to evaluate training requirements, training effectiveness, and when training is not required?
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Training departments
• QA managers and personnel
• Regulatory affairs
• Human resources (HR) managers and staff
• Documentation department
• Consultants
FDA Audit Best Practices - Dos and Don'ts
LIVE : Scheduled on
24-January-2025 :01:00 PM EST
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