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 document training so that it is readily available for review (by managers, auditors or inspectors).
Areas Covered in this seminar:
Who Will Benefit:
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.
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