Singapore Seminar on FDA Data Integrity for Computerized Systems

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 is 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.

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.

Location: Singapore Date: April 24th & 25th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: Mandarin Orchard Singapore

Address: 333 Orchard Road, Singapore 238867

Tel: (65) 6235 7788

Price:

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

Register for 5 attendees Price: $5085.00 $8,475.00 You Save: $3390.00 (40%)*

Until March 10, Early Bird Price: $1,695.00 from March 11 to April 22, Regular Price: $1,895.00

Quick Contact:

NetZealous DBA as GlobalCompliancePanel

Phone: 1-800-447-9407

Fax: 302-288-6884

Email: support@globalcompliancepanel.com

Website: http://www.globalcompliancepanel.com

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900946SEMINAR?channel=mailer&camp=seminar&AdGroup=20doctorshangout_april_2017_SEO

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