BEGIN:VCALENDAR X-WR-TIMEZONE:US/Eastern DTSTART:20180503T130000 DTEND:20180503T143000 VERSION:2.0 LOCATION:OnlinePRODID:-//Training Doyens //EN METHOD:REQUEST BEGIN:VEVENT DTSTAMP:20180503T000000 DTSTART;TZID="US/Eastern":20180503T130000 DTEND;TZID="US/Eastern":20180503T143000 SUMMARY:Computer Systems Validation DESCRIPTION: This will cover the history of Computer Systems Validation in the Pharmaceutical and Medical Device industries. This led to the regulation 21 CFR Part 11, which covers the management of both electronic signatures and electronic records. Compliance to relevant regulations using Standard Operating Procedures and required documentation will be covered.  The roles of Audits, Quality Assurance, and Risk Management will also be covered. PRIORITY:3END:VEVENT END:VCALENDAR