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Labcompliance Newsletter

Now you can get free update information on validation and compliance through an e-newsletter

Contents

  • News from FDA and other agencies: regulations, guidance documents, inspection and enforcement practices
  • News from industry task forces and other organizations, like ICH, ISPE, PDA, task forces etc.
  • Information and links to new literature for free  downloads from the Internet
  • New FDA warning letters, 483 inspectional observations and inspection reports.
  • Information on new conferences and seminars
  • Update on new products and services from Labcompliance
  • Regular update on Labcompliance seminars

Free Document of the Month

  • Every regular monthly Newsletter includes at least one Compliance Document for free. This may be an SOP, validation examples/checklists or templates, or a reference paper.

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Author of the Labcompliance Newsletter

Dr. Ludwig Huber is the author of the Labcompliance Newsletter. He has been conducting over 200 web and audio or video based seminars since fiften years. He is worldwide director for FDA compliance at Labcompliance.

  Dr. Ludwig Huber in a panel discussion with George Smith, FDA's national Computer Validation and Part 11 expert.

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 visits FDA in Rockville, VA, and participates in panel discussions with FDA professionals. For more information, click here.