21 CFR Part 11 Electronic Records: Electronic Signatures
Thursday, March 21, 2013 from 10:00 AM to 11:30 AM (PDT)
Palo Alto, CA
This 21CFR part 11 regulations training will review requirements for electronic record keeping and electronic signatures. It will help you ensure that your electronic data storage system is Part 11 compliant, mitigate the risk associated with non-compliance and provide tips on how to handle a FDA investigation related to electronic records.
Why Should You Attend:
Data storage in electronic format is the most convenient and makes it easy to access, share, copy, and edit. The security of electronic storage data is a major concern as the frequency and number of data breaches are increasing. Organizations using electronic systems to manage records or apply signatures via electronic means must understand and comply with certain minimum requirements laid down by the FDA in controlling and securing data. There have also been recent indications that FDA is increasing enforcement actions under 21 CFR Part 11 regulations.
This webinar will help attendees understand the importance of Part 11 compliant electronic systems and mitigate the liability, risks and brand damage associated with data security breaches. The webinar instructor will present from his experience in interpretation of this regulation starting with the creation of Part 11 and how most FDA Investigators approach this compliance area. It will prepare your organization to maintain the current electronic system according to industry best practices and to successfully handle FDA investigations for part 11 compliance.
Areas Covered in the Seminar:
This session will cover the following topics:
- Detailed review of 21CFR Part 11
- Discussion of key requirements
- How should an organization decide which systems fall under this Regulation
- How does an organization assure their systems are compliant
- What written procedures and training are required
- What are FDA Investigators looking for to asses compliance
When & Where
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- 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.