New Part 11 Guidance for Clinical Trials: What This Means for You
Friday, July 5, 2013 from 10:00 AM to 11:00 AM (PDT)
Palo Alto, CA
This training on 21 CFR Part 11 guidance for clinical trials will explain the new 21 CFR Part 11 regulations for electronic records and what that means for your organization and the clincial studies you conduct.
Why Should You Attend:
FDA regulations related to Good Clinical Practices includes Electronic Records and Electronic Signatures. Governing those is 21 CFR Part II. The Department of Health and Human Service equivalent to this regulation is 45 CFR 142 Security and Electronic Signature Standards and 45 CFR 160 and 162 Health Insurance Reform: Standards for Electronic Transactions.
This 60-minute webinar will help you to be aware of these regulations and what that means for your organization and study. For instance, you wish to scan your case report forms and keep them in an electronic format. Is this acceptable? A research participant wishes to email back his signed consent form. Is this acceptable? Are you set up to receive such documents? Information provided in this webinar will help answer these questions and more, and help you work through other complex scenarios that may arise.
Areas Covered in the Webinar:
- Requirements of 21 CFR Part 11
- Requirements of 45 CFR 142 and 160
- Electronic records:
- Why duties must be segregated to ensure integrity of data,
- Passwords and individual accounts:
- who needs them,
- how often to use,
- Data entry: proper protocol to follow for source data.
- Tips to get all staff on board in limiting access to authorized personnel only.
When & Where
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- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.