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Data Integrity, 21 CFR 11 & Annex 11 Implementation 2017

Data Integrity, 21 CFR 11 & Annex 11 Implementation 2017

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Who should attend?

VP of IT Director of IT Quality Managers Project Managers (for DATA INTEGRITY / IT) Validation Specialists Database Administrators System Administrators Directors / Senior Directors of Discovery Directors / Senior Directors of Development Directors / Senior Directors of Commercialization Document Managers Training Managers Consultants Data Managers Safety Managers

Details

Course "Data Integrity, 21 CFR 11 & Annex 11 Implementation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

 

Overview:

 

The Problem:

We have all heard of 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:

Evolution of 21 CFR Part 11 and Annex 11 and Why they are Back in the News

Overview and Key Requirements of Part 11 & Annex 11

How to use a Risk Based Assessment to reduce work while still achieving Data Integrity and Compliance?

How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity?

I often refer to 21 CFR 11 and Annex 11 as Good Software Engineering with the Documentation on Steroids! However, unless one knows how to implement Data Integrity, it is often very hard to apply requirements for DATA INTEGRITY to computerized system, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the agencies have stepped up data integrity inspections and the number of citations on the subject are skyrocketing!

This course is appropriate for beginner and experienced person alike. The topics will build on each other and will give you the latest trends in our heavily regulated industry and how to make it easy for yourself while still achieving data integrity.

This is a very hands-on class and the attendees will be given take away templates that will enable them to build a complete package to meet Data Integrity Requirements for Computerized Systems

 

 

 

Location: SFO, CA Date:  December 7th & 8th, 2017 and Time: 9:00 AM to 6:00 PM

Venue:  Hilton San Francisco Airport Bayfront   600 Airport Blvd, Burlingame, CA 94010, USA

 

 Price:

Price: $1,495.00 (Seminar Fee for One Delegate)

Register for 5 attendees   Price: $4,485.00 $7,475.00 You Save: $2,990.00 (40%)*

Register for 10 attendees   Price: $8,222.00 $14,950.00 You Save: $6,728.00 (45%)*

Register now and save $200. (Early Bird)

 

 

Contact us today!

 

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com 

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901052SEMINAR?pharmiweb-December-2017-SEO

 

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

 

 

Prices

Price: $1,495.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $4,485.00 $7,475.00 You Save: $2,990.00 (40%)* Register for 10 attendees Price: $8,222.00 $14,950.00 You Save: $6,728.00 (45%)*

Contact

Event Manager
john.robinson@globalcompliancepanel.com

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