Using Electronic and Digital Signatures in Regulated Environments

Speaker

Instructor: Dr. Ludwig Huber
Product ID: 702672

Location
  • Duration: 75 Min
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.
RECORDED TRAINING
Last Recorded Date: Jan-2013

 

$229.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$299.00
1 USB is for usage in one location only. info CD/USB and Ref. material will be shipped within 15 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

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.

Areas covered in this webinar:

  • Definitions of electronic vs. digital signatures.
  • Benefits of electronic signatures.
  • Examples of using e-signatures day-by-day.
  • Part 11 requirements for electronic signatures?
  • European and international requirements.
  • Applications and requirements of digital signatures.
  • Inspection and enforcement practices.
  • Specific software requirements for electronic signatures.
  • How to document the meaning of the signature.
  • Using digital pens for electronic signatures.
  • Validation of electronic signature software.
  • Certification of electronic signatures for the FDA.
  • FDA compliant training of accountability for e-signatures.
  • Using electronic signatures in Excel.

Who Will Benefit:

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

  • Everybody using computers in FDA regulated environment
  • Part 11 groups in Bio(pharmaceutical) and device industry
  • System owners
  • Software developers
  • IT managers and system administrators
  • QA managers and personnel
  • Analysts and lab managers
  • Training departments
  • Documentation department
  • Consultants
  • Regulatory affairs

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 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. Substitutions can happen any time.If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

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