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All documents shown here are included in the seminar for instant download

 

Frame work to develop your own Part11 project plan

 

 

 

Warning letters what FDA inspectors look for and what mistakes others make, so you can avoid them.

Learn from FDA 483's and from detailed EIR inspection reports  what FDA inspectors look for, what questions they ask and if company's response is satisfactory.  483's and EIR's typically are not available from FDA's public website.

 

Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for instant download. All reference material as listed below and more is available on a special seminar website. The website is regularly updated with most recent information. In case there are questions related to the topic, they can be submitted through a web form and will be answered by the speaker. For ordering info click here
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On-line Audio Seminar 301

Using Electronic and Digital Signatures in Regulated Environments

Comply with FDA Part 11 and with international regulations and guidelines

Recorded, available with all reference material at any time

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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.

Key questions about electronic and digital signatures are:

  • What are electronic signatures
  • What is the difference to digital signatures
  • What are the Part 11 requirements for e-signatures?
  • What are differences to other regulations, EU Annex 11
  • Which documents need to be signed
  • Are there any specific issues during FDA and other inspections
  • How to link signatures with records?
  • Are PDF signatures Part 11 compliant?
  • Can we use digital pens to create electronic signatures
  • How to 'certify' electronic signatures for FDA
  • How to avoid unapproved editing of e-signed documents?
  • How to use electronic signatures in Excel?

How does the on-line audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, the speaker will present strategies and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, gap analysis, implementation plan templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn:

  • 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

Get 10+ Documents To Do it Right The First Time:
download from special seminar website

  • Part 11 Compliance Master Plan
    -
    with section on electronic signatures
  • SOPs:
    - Using Electronic Signatures in FDA Regulated Environments
    - Access control to computer systems and data
  • Gap analysis/checklist:
    - 21 CFR Part 11
    - Using Electronic Signatures in Regulated Environments
  • Templates/examples
    - Requirement Specifications for Electronic Signatures
  • Example: Letter to the FDA about using Electronic Signature Certification
  • Example: Statement on Accountability for Electronic Signatures
  • Tutorial: Getting and using Digital Signatures for E-mails
  •  Warning letters and Inspectional observations related to Part 11 and signatures
  • FDA Regulation 21 CFR Part 11: Electronic Records and Signatures
  • EU GMP Annex 11: Using Computerized Systems
  • FDA Guidelines Related to 21 CFR Part 11
  • Unites States: Electronic Signatures in Global and National Commerce Act
    (E-sign act)
  • NIST Guidance on Implementing the electronic signatures in global
    and national commerce act (e-sign)
  • National Archive and Records Administration: Records Management Guidance for PKI Digital Signature Authentication and Secure Transaction Records
  • Directive 1999/93/EC of the European Parliament on a Community framework for electronic signatures (EU Digital signature directive)
  • PowerPoint Presentation
  • Script
  • All questions and answers from before, during and after the seminar

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
  • Validation professionals
  • Training departments
  • Documentation department
  • Consultants

Date, time and duration

Recorded seminar, available at any time with all reference material

How to order

Pick one of the options in the table that fits your needs.

Recorded seminar - Web Download

  • Multiple persons - single site
  • Learn at your desk, meet in a seminar or conference room or share the audio file and reference material at your site.
  • Order includes all reference material.

US$ 399.-
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Recorded seminar - CD

  • Get the CD in your mail
  • Order includes all reference material.

US$ 399.-
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Special offer for Labcompliance Usersclub Members
Recorded Seminar- CD or Web download.

  • Order includes all reference material.
  • for Usersclub information and registration, click here

US$ 299.-
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About audio seminars

Online audio seminars are presented over the phone. During the live presentation attendees can:

  1. Study the printed slide material
  2. Watch the slides on a computer
  3. Watch the slides on a video screen in a seminar room
  4. Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been conducting over 300 web and audio or video based seminars since 15 years and and he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health agencies.

Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and compliance, for example: Validation of Computerized Analytical and Networked Systems. He was or still is a member of several committees, e.g., of the GAMP® Special interest group (SIG) on Laboratory Computers, PDA Part 11 task force, IVT task force on network infrastructure qualification and the European Compliance Academy. He frequently visited FDA in Rockville, VA, and participated in panel discussions with FDA professionals. For feedback from attendees of seminars and  for other information on Dr. Ludwig Huber, click here.

. Ludwig Huber in Panel Discussions with FDA Officials

George Smith, FDA's national Part11 expert, at a panel discussion with Ludwig Huber during an IVT conference

Smith and Huber discussed and answered questions about computer system validation and e-records.
Ludwig Huber (right) and John Murray, FDA's Computer Validation Expert, (left), speaking at the IVT Computer System Validation Conference.
Mr. Murray explained FDA's next steps for Part 11


Ludwig Huber (right) in a panel discussion with FDA inspectors and directors:
 Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare,  and Nicholas Buhay,