21 CFR Part 11 and Annex 11 Compliance; specifics needed to eliminate 483s

Why Should You Attend:

This webinar describes exactly what is required to be 21 CFR Part 11 compliant. It takes the concepts of Part 11 and expands them into specific things to do in all three primary areas: SOPs, product features, and validation. All required IT SOPs are described. Product features based on the current industry standards are explained in detail. The 10-step risk-based validation approach is outlined so that the specific documents for a validation project are understood.

This is the first webinar in a series and it takes the mystery out of what is needed for 21 CFR Part 11 compliance. It will help you to eliminate 483s and Warning Letters.

This course is certified by Regulatory Affairs Professional Society (RAPS). Attendees of Live Webinar are eligible for 1.5 RAC Points up on full completion of the course

Areas Covered in the Seminar:

Which data and systems are subject to Part 11. 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.

Who Will Benefit:

Computer System users IT QA Managers Executives

Instructor Profile:
David Nettleton, Computer System Validation's principal, David Nettleton is an industry leader, author, and teacher for 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 200 mission critical laboratory, clinical, and manufacturing software implementation projects. His latest book is "Risk Based Software Validation - Ten easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006) which provides fill-in-the-blank templates for completing a COTS software validation project.

NOTE : Use this Promocode (128600)to avail 10% discount,Valid till December 30 & add another webinar to your shopping cart and get 20% off on its price.

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