Monday 8th July, 2013
9:00am to 6:00pm
This course will teach you how to reduce software validation costs by as much as two thirds.
It details all the requirements for 21 CFR Part 11 and HIPAA that relate to SOPs, software features, and risk-based validation.
The course is highly interactive, using real life examples and proven techniques.
You will learn how to use electronic records and electronic signatures to maximize productivity.
This course will teach you how to prepare for an audit and is intended for IT, QA, laboratory, clinical, and manufacturing staff, as well as software vendors.
Lecture 1: Introduction to the FDA
Lecture 2: 21 CFR Part 11 - Compliance for Electronic Records and Signatures
Lecture 3: HIPAA Compliance for Electronic Records
Lecture 4: The Five Keys to COTS Computer System Validation
Lecture 5: The Validation Team
FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation
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