Validation and 21 CFR Part 11 Compliance of Computer Systems

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.

Description:

The Problem

We have all heard of Computer Systems Validation & Data Integrity, but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following:

• 21 CFR Part 11 and Computer Validation: Why so many citations?
• Computer Systems Validation (CSV) and 21 CFR 11 vs Annex 11
• Data Integrity vs Computer Systems Validation
• Overview and Key Requirements of Part 11 & CSV
• How to use a Risk Based Assessment to reduce work while still achieving Compliance?
• How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity?

Location:  Philadelphia, PA Date: October 4th & 5th, 2018 and Time: 9:00 AM to 6:00 PM

Venue:  DoubleTree by Hilton Philadelphia Airport   4509 Island Avenue, Philadelphia, PA 19153

Price:

Price: $1,295.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*

Register now and save $200. (Early Bird)

Sponsorship Program benefits for seminar

For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com

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Registration Link - https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901858SEMINAR?seo

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