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

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


About The Event


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.

Areas Covered in the Webinar:

Which data and systems are subject to Part 11 and Annex 11
What the regulations mean, not just what they say
Avoid 483s and Warning Letters
Explore the three primary areas of compliance: SOPs, software product features, and validation documentation
Learn the requirements for IT, SaaS, and cloud hosting
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 personnel
QA personnel

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

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