Conference on Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced

14 July 2016 09:00 - 15 July 2016 18:00

Course “Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced” 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.
The attendees must have attended the Basic Validation & 21 CFR 11 Compliance. This is a very hands-on class and the attendees will be expected to use templates provided in the class to create the complete package for the validation of a system
The Seminar:
This Hands-On course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation as follows:
1. Validation Master Plan
2. Complete Validation for a System
3. Excel Spreadsheet Validation
4. Change Control
5. SOPs
6. Test Tools Validation
7. Project Management for Validation
Industries:
• Pharmaceuticals
• Biotech
• Medical Device
• Radiological Health
• Blood Products
• Companion Animals
• Food
• Cosmetics
• Tobacco
• Academia
Speaker:
Angela Bazigos
CEO, Touchstone Technologies Silicon Valley
Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. “Your Passport to Compliance”. She has 30 years of experience in the Lifesciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance.
Ms. Bazigos is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to investment groups on Lifesciences investments as well as Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management both to investor groups and industry.
Location: SanFrancisco, CA Date: July 14th & 15th, 2016 and Time: 9:00 AM to 6:00 PM

Venue: DoubleTree by Hilton Hotel San Francisco Airport
Address: 835 Airport Blvd, Burlingame, CA 94010, USA

Price:

Without Stay – Price: $1,495.00

With Stay – Price: $1,895.00

Get fabulous discounts by participating in groups of 2 or more
Special Offer, Register for 5 attendees (With Accommodation) Includes Price: $6,633.00 (Flat 30% OFF – You Save $2,842.5 (30%)

Quick Contact:
NetZealous DBA as GlobalCompliancePanel
Email: [email protected]
Phone: 1-800-447-9407
Fax: 302-288-6884

Registration Link – http://globalcompliancepanel.viewpage.co/Validation-and-21-CFR-11-Compliance

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