Thursday 18th April, 2013
9:00am to 6:00pm
Lecture 1: Introduction to the FDA
How the regulations help your company to be successful
Which data and systems are subject to Part 11.
Lecture 2: 21 CFR Part 11 - Compliance for Electronic Records and Signatures
What Part 11 means to you, not just what it says in the regulation.
Avoid 483 and Warning Letters.
Explore the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation.
Ensure data integrity, security, and protect intellectual property.
Understand the current computer system industry standards for security, data transfer, and audit trails.
Electronic signatures, digital pens, and biometric signatures.
SOPs required for the IT infrastructure.
Product features to look for when purchasing COTS software.
Reduce validation resources by using easy to understand fill-in-the-blank validation documents.
Lecture 3: HIPAA Compliance for Electronic Records
How Part 11 and HIPAA interrelate
What are the additional requirements for patient data
Lecture 4: The Five Keys to COTS Computer System Validation
The Who, What, Where, When, and Why of CSV
Lecture 5: The Validation Team
How to select team members
How to facilitate a validation project
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18th–19th April 2013