Web Seminar: Using Electronic Signatures in FDA and EMA Regulated Environments

Sept. 17, 2012 - PRLog -- Why to attend:
   
FDA and equivalent regulations such as Part 11 and the EU GMP Annex 11 allow to sign electronic records with electronic 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 signatures. Therefore most companies are unsure about electronic signatures that they print out copies of electronic records and sign the paper. During the seminar, the speaker will present FDA and EU requirements and will give practical recommendations. After the seminar, an extensive list of reference material like SOPs, templates and examples will help trouble-free implementation.

Areas Covered in the Seminar:

* 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 for Excel

And for easy and instant implementation:
download 10+ best practice guides from special seminar website.
They include

* Part 11 Compliance Master Plan - with section on electronic signatures
* SOP: Using Electronic Signatures in FDA Regulated Environments
* Gap analysis/checklist: 21 CFR Part 11
* Checklist: Using Electronic Signatures in Regulated Environments
* Detailed Comparison: 21 CFR Part 11 and EU GMP Annex 11
* Example: Requirement Specifications for Electronic Signatures
* Example: Letter to the FDA about using Electronic Signature Certification
* Example: Statement on Accountability for Electronic Signatures
* FDA Warning letters related to Part 11 and signatures
* PowerPoint Presentation with all slides
* Script of the presentation
* All questions and answers from before, during and after the seminar

Date:  November 15,2012
Time: 11.00 - 12.00 a.m. ET
Location: Online, worldwide

Who should attend
* 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

Weblink:  http://www.labcompliance.com/seminars/audio/301/default.aspx

Presenter: Dr. Ludwig Huber

Category: Pharmaceutical, API Manufactuer, Medical Device Manufacturer FDA, Training

Ludwig Huber, Ph.D., is Director for global FDA compliance at Labcompliance. He is the author and editor of www.labcompliance.com, the global on-line resource for validation and (laboratory) compliance. Dr. Huber has been presenting more than 200 web, video and audio seminars. He has been selected as IVT's "Presenter of Year" out of 175 presenters. He is also the author of more than 100 papers about FDA and international compliance (including the bestselling books “Validation of Computerized Analytical Systems” and “Validation and Qualification in Analytical Laboratories)”. Currently, Dr. Huber is on the Scientific Advisory board of IVT’s GxP and Validation Journals, and he has given multiple presentations and workshops mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included workshops and presentations for the  US FDA, ISPE, PDA, PDA, PIC/S and several national health agencies including China SFDA