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 GAMP, PDA task forces etc.
• Information on new literature for free electronic ordering or download from the Labcompliance Usersclub.
• New FDA warning letters and inspection reports.
• Information on new conferences.
• News on computer system validation, network qualification, and on equipment qualification
• News on FDA's Part 11 and other regulations
• Update on new products and services from Labcompliance

Free Document of the Month

• Starting February 2008 every regular monthly Newsletter will include 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 Author Newsletter

Dr. Ludwig Huber is the author of the Labcompliance Newsletter. He has been conducting over 100 web and audio or video based seminars since ten years. He is worldwide director for FDA compliance at Agilent Technologies.

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.