Audio Seminars

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10+ Best Practices Reference Documents: All included in the seminar

The reference website includes examples for a test plan, test script, test traceability matrix and a test summary report.

The reference material includes links to FDA and international regulations related to computer systems. 

The handout includes examples for warning letters related to Part 11 and Computer systems  

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.

On-line Audio Seminar 186

Validation and Part 11 Compliance of Electronic Document Management Systems

- With Validation Examples from Planning to System Retirement -

Recorded

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Document management systems are increasingly used to acquire, review, sign, manage  and archive  data and other records. When used in FDA regulated environments they should be validated and comply with specific regulations and guidelines for electronic records and signatures. There are no specific FDA or other guidelines for EDMS. The questions are how much validation is enough and how to ensure accuracy, reliability and integrity of records?

Key Questions related to Electronic Document Management Systems (CDS) are

  • What and how much to test?
  • Are vendor audits required?
  • How to define risk categories?
  • Should we test standard functions of EDMS?
  • Haw to validate networked EDMS systems?
  • How to validate existing systems?
  • What to revalidate and document after changes?
  • How to ensure and document system security and data integrity?
  • How to validate EDMS for Part 11 compliance?

How does the 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, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • FDA and EU requirements for CDS - What do inspectors ask and what documents should be available.
  • Most frequently cited deviations related to EDMS.
  • How to develop a validation master plan for a EDMS?
  • How to write a user requirement specification document?
  • How to qualify vendors of commercial EDMS
  • Validation steps: DQ/IQ/OQ/PQ
  • Recommendations for risk based validation.
  • Validation of existing systems
  • Validation of networked EDMS
  • How to ensure and validate integrity of test results.
  • How to plan, implement and document EDMS retirement
  • Validation of networked EDMS and infrastructure.
  • How to document planning, specifications, installation, testing and changes
  • Critical steps to comply with FDA's Part11
  • Going through case studies

And for easy and instant implementation:
download 10+ documents from special seminar website

  • SOPs:
    - Validation of Electronic Document Management Systems
    - Risk Assessment for Computer Systems
    - Retirement of Computer Systems
    - Retention and Archiving of Electronic Records
  • Gap analysis:
    - Commercial Off-the-shelf Computer Systems
    - FDA Record Retention and Retrieval
  • Templates/Examples for Electronic Document Management Systems
    - Validation from beginning to the end
    - Project plan
    - Requirement Specifications
    - Vendor qualification
    - Design Qualification
    - Installation qualification
    - Operational qualification
    - Performance qualification
    - Test plan
    - Validation report
  • FDA 483 inspectional observations and warning letters with deviations related to computers systems
  • FDA regulations and guidelines related to computers and electronic records
  • And more....

Who should attend?

  • Documentation department manger and staff
  • QA managers and personnel
  • IT administrators
  • Validation specialists
  • Regulatory affairs
  • Human resources (HR) managers and staff
  • Training departments
  • Users of regulated document management systems
  • Consultants

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.