21 CFR Part eleven as well as Annex 11 Compliance; specifics needed to eliminate 483s

Why Should You Attend:

This web seminar describes just what exactly is essential to always be 21 CFR Part 11 compliant. It usually takes the particular aspects associated with Part 11 and swells these individuals straight into unique requirements overall several principal areas: SOPs, product or service features, and validation. All necessary IT SOPs are described. Product features according to the current industry standards are usually discussed within detail. The 10-step risk-based validation approach is actually defined making sure that the suitable files for a validation venture are generally understood.

This is usually that first webinar within a series also it usually takes your secret out of what exactly is wanted for 21 CFR Part 11 compliance. It can help you to eliminate 483s and Warning Letters.

This course is certified by means of Regulatory Affairs Professional Society (RAPS). Attendees with Live Webinar meet the criteria pertaining to 1.5 RAC Points through to whole completion belonging to the course

Areas Covered in the Seminar:

Which files and methods will be subject to Part 11. What Part 11 way to you, not just just what exactly them claims inside the regulation. Avoid 483 and Warning Letters. Explore the actual a few primary regions of Part 11 compliance: SOPs, software package product or service features, and also validation documentation. Ensure information integrity, security, and also safeguard rational property. Understand the existing laptop or computer method community requirements for security, info transfer, as well as review trails. Electronic signatures, electronic digital pens, along with biometric signatures. SOPs necessary to the IT infrastructure. Product features to check with regard to when buying COTS software. Reduce validation resources by employing great 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 surely an sector leader, author, in addition to teacher regarding 21 years old CFR Part 11, Annex 11, HIPAA, software program validation, and also personal computer system validation. He is usually involved with that development, purchase, installation, functioning as well as protection involving online models used in FDA compliant applications. He features concluded in excess of 200 objective critical laboratory, clinical, as well as manufacturing software package rendering projects. His most up-to-date reserve is "Risk Based Software Validation - Ten uncomplicated Steps" (Davis Horwood International plus PDA - www.pda.org, 2006) which provides fill-in-the-blank web themes regarding setting up a COTS program validation project.

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