21 CFR Part eleven and Annex 11 Compliance; main features were required to remove 483s

Why Should You Attend:

This webinar details just what exactly is needed being 21 CFR Part 11 compliant. It requires the aspects involving Part 11 plus grows all of them towards distinct things to do within most several primary areas: SOPs, item features, plus validation. All necessary IT SOPs are described. Product capabilities determined by the existing marketplace criteria are usually explained with detail. The 10-step risk-based validation strategy is definitely discussed to ensure that the specific documents intended for a validation task are understood.

This may be the earliest webinar within a string and it will take your mystery out there connected with what the heck is required for 21 CFR Part 11 compliance. It will assist you for you to wipe out 483s and also Warning Letters.

This study course is definitely certified by simply Regulatory Affairs Professional Society (RAPS). Attendees of Live Webinar considered to get 1.5 RAC Points through to total completion on the course

Areas Covered inside the Seminar:

Which records and systems are subject matter to Part 11. What Part 11 means to you, not just what it claims in the regulation. Avoid 483 in addition to Warning Letters. Explore the a few main instances of Part eleven compliance: SOPs, software program solution features, as well as validation documentation. Ensure facts integrity, security, in addition to protect intellectual property. Understand the contemporary computer system business criteria for security, files transfer, and taxation trails. Electronic signatures, handheld pens, in addition to biometric signatures. SOPs essential for the IT infrastructure. Product characteristics to find while buying COTS software. Reduce validation resources by utilizing simple to implement fill-in-the-blank validation documents.

Who Will Benefit:

Computer System users IT QA Managers Executives

Instructor Profile:
David Nettleton, Computer System Validation's principal, David Nettleton is a great community leader, author, in addition to teacher regarding 21 CFR Part 11, Annex 11, HIPAA, software validation, in addition to computer technique validation. He is involved with the development, purchase, installation, operations along with upkeep with computerized programs found in FDA compliant applications. He has finished a lot more than 200 mandate essential laboratory, clinical, along with creation computer software enactment projects. His hottest e-book is definitely "Risk Based Software Validation - Ten easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006) which supplies fill-in-the-blank templates intended for handing in a COTS software validation project.

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