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Using Electronic and Digital Signatures in Regulated Environments
Thursday, January 24, 2013 from 10:00 AM to 11:15 AM (PST)
Palo Alto, CA
This webinar will familiarize you with FDA requirements for electronic and digital signatures, and the agency's inspection and enforcement practices. Particpants will recieve complimentary hand-outs for easy implementation.
Why Should You Attend:
FDA Part 11 and other regulations such EU GMP Annex 11 allow to sign electronic records with electronic and digital signatures. Benefits for regulated user firms are increased overall efficiency and reduced costs for handling and storing paper records. While nearly all Part 11 related papers and seminars deal with requirements of electronic records there is hardly any information about electronic and digital signatures. Therefore most companies are unsure about electronic signatures such that they print out copies of electronic records and sign the paper.
In this seminar attendees will become familiar with FDA requirements for electronic and digital signatures.
For easy implementation, attendees will receive
- 2 SOPs
- Using Electronic Signatures in FDA Regulated Environments.
- Access Control to Computer Systems and Data.
- Checklist: Using Electronic Signatures in Regulated Environments.
- Example: Requirement Specifications for Electronic Signatures.
- Tutorial: Getting and using Digital Signatures for E-mails.
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- 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.