Seminar on Validation and 21 CFR 11 Compliance of Computer Systems Intermediate to Advanced at San Diego, CA

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

Location: San Diego, CA Date: July 14th & 15th, 2016 and Time: 9:00 AM to 6:00 PM

Venue: WILL BE ANNOUNCED SOON , San Diego, CA

Price Details:

(Seminar Fee for One Delegate Without stay)-Price: $1,295.00  

Until May 31, Early Bird Price: $1,295.00 From June 1 to July 12, Regular Price: $1,495.00

(Seminar Fee for One Delegate With stay)-Price: $1,695.00  

Until May 31, Early Bird Price: $1,695.00 From June 1 to July 12, Regular Price: $1,895.00

Quick Contact:

NetZealous DBA as MentorHealth

Phone: 1-800-385-1607

Email: support@mentorhealth.com

Website: http://www.mentorhealth.com/

Registration Link - http://www.mentorhealth.com/control/globalseminars/~product_id=200049SEMINAR

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