FDA 21 CFR Part 11 Compliance - Validation Seminar 2018

  • Check with publisher
  • Published date: April 2, 2018
    • Germany

Course "Validation and 21 CFR Part 11 Compliance of Computer Systems" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV.
Speaker
Angela Bazigos
CEO, Touchstone Technologies Silicon Valley


Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety and Turnarounds.
Location: Germany Date: May 3rd & 4th, 2018 and Time: 9:00 AM to 6:00 PM
Venue: WILL BE ANNOUNCED SOON
Price:
Price: $1,695.00 (Seminar Fee for One Delegate)
Register for 5 attendees Price: $5,085.00 $8,475.00 You Save: $3,790.00 (40%)*
Register for 10 attendees Price: $9,322.00 $16,950.00 You Save: $8,528.00 (45%)*
Register now and save $200. (Early Bird)
Until March 31, Early Bird Price: $1,695.00 From April 01 to May 01, Regular Price: $1,895.00
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