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Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements in a Relatively Paper-Free Manner

Training Options

  •   Duration: 60 Minutes  
  • Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
    Price: US$275.00
  • Refund Policy

Overview:

A document control system is required for compliance with federal (FDA) and international (ISO) compliance.

Implementation, performance, and maintenance of a compliant document control system can be time-consuming and costly. This webinar reviews FDA and ISO requirements for document control. This webinar also offers a cost-effective, time-saving alternative to a typical document control system.

Areas Covered in the Session:
  • History of document control
  • FDA requirements for document control
  • ISO 13485 requirements for document control
  • Elements/practices of a typical document control system
  • Elements/practices of a streamlined document control system
  • How to use electronic systems for document control, WITHOUT 21 CFR part 11 implications

Who Will Benefit:
  • Regulatory Management
  • Quality Assurance Professionals
  • Consultants
  • Sales/Marketing Management
  • Senior and mid-level Management
  • Quality System Auditors
Speaker Profile
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. 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.


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