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Using Electronic and Digital Signatures in Regulated Environments

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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.

Speaker
Instructor: Dr. Ludwig Huber
Product ID: 702672

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.

Free Hand-outs:

For easy implementation, attendees will receive

Areas covered in this webinar:

Who Will Benefit:

Pharmaceutical and medical device manufacturers, clinical contract reasearch organizations, contract laboratories and API manufacturers will benefit.

Instructor Profile:

Ludwig Huber , Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance for Agilent Technologies. He is the editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare.

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Refund Policy
"Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance.
ComplianceOnline would process/provide refund only if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs."
For substitution, please email editor@complianceonline.com or call +1-650-620-3937.

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Training Options Training Duration = 75 Min
$399.00 Access Recorded Version Only
One Person - Unlimited viewing for 6 Months
(For multiple licenses contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
$599.00 Get Training CD Only
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days