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

Some of these sessions are too basic - this one had a good mix of basic and details. The tips are helpful. One comment: a little more discussion regarding the use of Detection in FMEAs would be useful since many do not advocate its use. Thanks,

I especially liked that the Q&A session after the webinar was long enough to not only address my own questions but also to learn from the questions from the other participants in the webinar.

Very thorough understanding of the history/progression of the guidances, and very helpful evaluation of current and potential directions. Excellent presentation skills, very engaging.

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

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

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Instructor : Jeff Kasoff

Product Id : 600063

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

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy and colonoscopy devices, where he oversees the operation of the quality system. In this position, Jeff is responsible for oversight of the document control system, including maintenance of regulatory documentation. Prior to this, Jeff spent 13 years at Life-Tech, Inc. as the Director of Regulatory Affairs, where he was responsible for compliance of the corporate quality system. Jeff received his regulatory affairs certification in 1996.

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