Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents

Date : 4th December 2018 to 4th December 2018

Place : United States, Palo Alto

Website :https://www.complianceonline.com/drafting-a-software-v-and-v-documentation-package-and-protocol-21cfr-part-11-er-es-webinar-training-704848-prdw?channel=allconferencealerts

Contact Person: Ashutos Swain

Description:

A tougher U.S. FDA expects a company to maintain certain documents in equipment, process and product software V&V. These documentation requirements can assist in a 21 CFR Part 11 CGMP records / signature V&V as well. This training program will provide valuable assistance to all regulated companies in evaluating their existing or anticipated software V&V activities and documentation requirements, especially in light of the changes in the FDA's stance vis a vis industry compliance, past problems, and the growing cloud environment. It will help attendees understand and recognize the most common software V&V failings and their fixes. The webinar will allow attendees to develop and use a repeatable software V&V template for all software validation projects.

Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents will be held in Palo Alto,United States on date 2018-12-04

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Deadline for abstracts/proposals : 2nd December 2018

Keynote Speakers :

Check the event website for more details.