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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 181

Documentation for FDA Compliance

- Step-by-step Instructions with Sample Documents -

Recorded

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Documentation is most important in the regulated world. "If it is not documented, it is a rumor" is a famous saying when dealing with FDA and other agencies. "Documentation not available", or "Documentation not adequate" are most frequently cited deviations in FDA Warning Letters. With a good understanding of the regulations, good common sense, good science or good engineering it is easily possible to be in compliance with technical requirements, however to comply with documentation is not so easy. It is not enough, to have everything documented, it is equally important to have the right documents with the right format. This is where the industry struggles with.

Key Questions related to FDA Compliant Documentation:

  • Where can I find which documents we need for FDA?
  • Which documents are required for EU inspections?
  • Does the FDA or EU require specific contents or formats?
  • Who is responsible for documentation?
  • What is the right format for each document?
  • Who should review, approve and sign documents?
  • Do we always need SOPs or can we use our installation and test scripts?
  • For how long should we keep the documents?
  • What is the best media for document archiving: electronic, paper or microfiche?
  • I want to archive all my documents electronically, can I scan my paper and destroy the paper
  • How useful are document management systems and should they comply with 21 CFR Part 11?

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:

  • Documents required by the US-FDA
  • Documents required by international agencies
  • Developing an SOP for generation and maintenance of documentation
  • Handling electronic documents
  • Managing documents: Electronic vs. paper
  • Archiving paper documents electronically
  • Preparing documentation for national and international inspections
  • Compliance of electronic document management systems
  • Practical tips for writing documents
  • Going through examples
    - master plans
    - SOPs
    - test protocols
    - validation documents
    - batch records
    - training records

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

  • SOPs:
    - Development and maintenance of SOPs
    - Document management and control
    - Development and maintenance of test scripts
    - Scanning of Paper Records for GxP Compliant Archiving
    - Retention and Archiving of Electronic Records
  • Examples
    - Test traceability matrix
    - Test scripts
    - Requirement specifications: good and bad exampes
    - Validation documents
    - Training records
  • Regulatory reference documents:
    - FDA Drug cGMP: Requirements for Laboratory Records
    - FDA Drug cGMP: Requirements for Manufacturing Records
    - FDA CGP: Requirements for Clinical Trials Records
  • Five Warning letters and/or Inspectional observations related to documentation
  • FDA guidance documents and predicate rules

Who should attend?

  • Documentation department manager and staff
  • QA managers and personnel
  • Analysts and lab managers
  • Validation specialists
  • Regulatory affairs
  • Human resources (HR) managers and staff
  • Training departments
  • Documentation department
  • 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.