What is Process Validation Report | 21CFR11 Compliance Checklist 2018

  • 1695.00 Dollar US$
  • Published date: November 9, 2017
    • Germany, Germany, 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.
This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools



Location: Germany Date: January 11th & 12th, 2018 and Time: 9:00 AM to 6:00 PM
Venue: WILL BE ANNOUNCED SOON , Germany

Price:
Price: $1,695.00 (Seminar Fee for One Delegate)
Register now and save $200. (Early Bird)
Until December 15, Early Bird Price: $1,695.00 From December 16 to January 07, Regular Price: $1,895.00
Register for 5 attendees Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)*
Register for 10 attendees Price: $9,322.00 $16,950.00 You Save: $7,628.00 (45%)*
Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry”
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NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
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