Document Approval Control and Distribution How to Meet FDA QSR and ISO 13485 Requirements in a Re
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:
Quality Assurance Professionals
Senior and mid-level Management
Quality System Auditors
Jeff Kasoff, RAC, CQM, is the Director of Quality at Medivators, a leading manufacturer of consumables and instrumentation in the endoscopy field. Among his responsibilities is oversight of the document control system.
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
Event Link - http://bit.ly/15oyBrQ
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