PRE-REGISTRATION AVAILABLE If you want to have this training scheduled Live and Exclusively for your company, we will arrange it for you. Pre-Register now and pay only once the training is scheduled on your preferred days. Click on the button below to pre-register
If you want to have this training scheduled Live and Exclusively for your company, we will arrange it for you.
Pre-Register now and pay only once the training is scheduled on your preferred days.
|SEMINAR OBJECTIVES||WHO SHOULD ATTEND|
DAY 1 (9 AM to 3 PM Pacific Time)
09:00 AM - 10:00 AM: Introduction to the FDA
10:00 AM - 02:00 PM: 21 CFR Part 11/Annex 11 - Compliance for Electronic Records and Signatures
* Includes two 10 minute breaks and a 40 Minute Lunch break
02:00 PM - 02:30 PM: The Five Keys to COTS Computer System Validation
02:30 PM - 03:00 PM: The Validation Team
DAY 2 (9 AM to 3 PM Pacific Time)
09:00 AM - 10:30 AM: Ten-Step Process for COTS Risk-Based Computer System Validation
* Includes a 10 Minute break
10:30 AM - 11:00 AM: How to Write Requirements and Specifications
11:00 AM - 12:00 PM: How to Conduct a Hazard Analysis/Risk Assessment-Exercise
12:00 PM - 01:15 PM: Software Testing
* Includes a 40 Minute Lunch Break
01:15 PM - 02:00 PM: How to write a Data Privacy Statement
* Includes a 10 minute break
02:00 PM - 02:30 PM: Purchasing COTS Software
02:30 PM - 03:00 PM: Cost Reduction Without Increasing Regulatory or Business Risk
David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is “Risk Based Software Validation – Ten easy Steps” that relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 185 mission critical software validation projects.