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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 184

Cost Effective Electronic Data Archiving for FDA Compliance

- Understanding and Implementing the New GAMP Guide -

Recorded

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With the increasing amount of data generated during development and manufacturing and drugs and medical devices companies are looking for more efficient data archiving strategies. Electronic data archiving is the way to go because of lower storage cost.  Electronic data are also easier to search at the same and between different sites. However, the industry is unsure what the best strategy is for FDA compliance and highest efficiency.

Key Questions related to Electronic Data Archiving:

  • What are FDA's and international requirements
  • Are there any standards for archiving?
  • What data have to be archived: raw data, meta data, final results?
  • Which file format should we use: PDF, TIF, XML?
  • Which data need reprocessing, for how long?
  • Are there any vendor neutral file formats for reprocessing
  • How to migrate data to new systems, how many samples to validate?
  • What is the best storage medium for long term archiving 
  • What to do with e-mails?
  • How to convert paper documents for electronic archiving?

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 international requirements: GMP/GLP/GCP and Part11
  • Driving forces and benefits of electronic data archiving
  • Issues with electronic archiving
  • Recommendations from GAMP
  • Type of data: raw data, meta data, final results
  • Requirements for e-mails and attachments
  • Options for e-archiving: standard files, proprietary formats
  • Vendor neutral file formats
  • Storage media for long term archiving
  • Record maintenance during the archiving period
  • Scanning paper for electronic archiving
  • Requirements for electronic archiving systems
  • Archiving strategies
  • Recommendations for implementation

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

  • SOPs:
    - Retention and Archiving of Electronic Records
    - Scanning of Paper Records for GxP Compliant Archiving
    - Archiving of GLP data and other documents
    - Archiving and retrieval of GMP data and other documents
    - Validation of an Electronic document management system
  • Checklist: FDA Record retention and retrieval
  • NIST Publication: Care and Handling of CDs and DVDs - A Guide for Librarians and Archivists
  • Regulatory reference documents:
    - FDA Drug cGMP: Requirements for Laboratory Records
    - FDA Drug cGMP: Requirements for Manufacturing Records
    - FDA GCP: Requirements for Clinical Trials Records
  • Five Warning letters and/or Inspectional observations related to electronic data
  • 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.