Now you can get free update information on
validation and compliance through an e-newsletter
- 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
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- Information on new conferences and seminars
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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,