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+1-888-771-6965
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Location: Scottsdale, AZ | January 31- February 01, 2018 |
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This Computer System
Validation Training course will explore proven techniques for reducing
costs associated with implementing, using, and maintaining computer
systems in regulated environments. Today, the FDA performs both GxP and
Part 11 inspections, the Europeans have released an updated Annex 11
regulation that expands Part 11 requirements and companies must update
their systems and processes to maintain compliance. |
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- Understand what is expected in Part 11 and Annex 11 inspections
- Avoid 483s and Warning Letters
- Learn how to buy COTS software and qualify vendors
- Implement a computer system using
risk-based validation to gain maximum productivity and reduce cost
by as much as two thirds
- Requirements for local, SaaS, and cloud hosting
- How to select resources and manage validation projects
- "Right size" change control methods that allows quick and safe system evolution
- Minimize the validation documentation to reduce costs without increasing regulatory or business risk
- Write test cases that trace to elements of risk management
- Protect intellectual property and keep electronic records safe
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Day 1
- Introduction to the FDA (1 hr)
- 21 CFR Part 11 - Compliance for Electronic Records and Signatures (4 hr)
- HIPAA Compliance for Electronic Records (30 minutes)
- The Five Keys to COTS Computer System Validation (30 minutes)
- The Validation Team (30 minutes)
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Day 2
- Ten-Step Process for COTS Computer System Validation (1 hr)
- How to Write Requirements and Specifications (30 minutes)
- How to Conduct a Hazard Analysis/Risk Assessment-Exercise (30 minutes)
- Software Testing (1 hr)
- System Change Control (30 minutes)
- Purchasing COTS Software (30 minutes)
- Cost Reduction Without Increasing Regulatory or Business Risk (1 hr)
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Download Seminar Brochure |
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David Nettleton,
FDA Compliance Specialist, Computer System Validation
Computer System Validation’s principal, David Nettleton is an
industry leader, author, and teacher for 21 CFR Part 11, Annex 11,
HIPAA, software validation, and computer system validation. He is
involved with the development, purchase, installation, operation and
maintenance of computerized systems used in FDA compliant
applications... |
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Location:
Scottsdale, AZ | January 31- February 01, 2018
(Venue to be announced shortly)
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| One Registration - USD 1,299 |
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Your registration fee includes the seminar, all course materials and lunch.
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Please forward this email to your friends or colleagues |
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GRCSeminars http://www.grcseminars.com
2479 East Bayshore Road, Suite 200, Palo Alto, CA 94303
Copyright © 2017 GRCSeminars.com |
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