Training Requirements and Practices to Assure QSR and ISO Compliance

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 document training so that it is readily available for review (by managers, auditors or inspectors).

Areas Covered in this seminar:

• 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

Who Will Benefit:

• Training departments
• QA managers and personnel
• Analysts and lab managers
• Validation specialists
• Regulatory affairs
• Human resources (HR) managers and staff
• Documentation department
• Consultants

Instructor Profile:

Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.

Follow us :