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FDA Electronic Recordkeeping & Signatures - 21 CFR Part 11

On-Site Training

Training Seminar

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Get the latest information on 21 CFR Part 11. A lot has been said and conjuctured about Part 11. Get the real story and what you need to be doing about it. FDA has published the “Scope and Application” guidance as related to 21 CFR Part 11 in addition to the withdrawal of multiple Part 11 guidance and compliance policy. It is important for companies to keep in mind that 21 CFR Part 11 is still in effect. FDA promulgated Part 11 to provide criteria for acceptance of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper. This seminar provides a complete overview of Part 11 and addresses the latest legal and regulatory compliance concerns while presenting case studies by FDA regulated manufacturers to highlight current strategies for how to address Part 11 in light of this latest FDA guidance. This course is applicable to executives, Information Technology Professionals, Legal, and RA/QA Managers responsible for implementing and maintaining regulatory compliance aspects of electronic recordkeeping systems. It is also beneficial for software development, software validation, manufacturing, and quality systems personnel. Audit Checklists will be presented that can be used to demonstrate effective compliance with Part 11 per FDA latest guidance.

What you will learn:

Benefits of Attending:

Abbreviated Outline:

Speakers:  Dennis Rubenacker

Contact us at: info@noblitt-rueland.com

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