21 CFR Part 11 and Annex 11 Compliance - Specifics Needed to Eliminate 483s

This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).

Why Should You Attend:

This webinar will describe exactly what is required for compliance with Part 11 and the updated European equivalent Annex 11. It will take the concepts described in the regulations and expand them into specifics for all three primary compliance areas: SOPs, product features, and validation. Attendees will learn what is required for IT, SaaS, and cloud hosting. All required IT SOPs will be described. Product features based on the current industry standards will be explained in detail. The 10-step risk-based validation approach is outlined so that the specific documents for a validation project are understood.

Who Will Benefit:

• Computer system users
• IT personnel
• QA personnel
• Managers
• Executives

Instructor Profile: 

Computer System Validation’s principal, David Nettleton, is an industry leader, author, and instructor on topics pertaining to 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. He has completed more than 250 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten Easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project. 

Note:

Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

http://www.complianceonline.com/fda-21-cfr-part-11-compliance-requirements-computer-system-validation-webinar-training-701687-prdw?channel=sciencedz