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Dr. Ludwig Huber

Director,

Dr. Ludwig Huber Ph.D., is the director and editor of Labcompliance the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare". He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. For more information, please visit Dr. Huber’s website www.ludwig-huber.com



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  • Recorded
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  • 75 Minutes
  • ¤190.00
Understanding the USP Chapter 1224 for Transfer of Analytical Methods

When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.

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  • 75 Minutes
  • ¤190.00
Validation of Analytical Methods and Procedures

Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years and new official guidelines have been published by FDA, EMA and USP in the last 4 years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.

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  • 3 Hours
  • ¤340.00
3-Hour Virtual Seminar on FDA's New Enforcement of 21 CFR Part 11

FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program.

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  • 75 Minutes
  • ¤190.00
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments

Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.