Dr. Ludwig Huber
Director and Chief Editor, Labcompliance
Ludwig Huber, Ph.D., is the director of Lab compliance, 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". He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world.

Upcoming Webinar
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Recorded Webinar
Transfer of Analytical Methods and Procedures according to USP 1224
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. For a long time there was no official guidance on what exactly is expected to maintain 'the validated state'. Now the USP has published an updated general chapter <1224>. Also the FDA has released an official guidance on how to conduct and document method transfer. In addition the FDA has included requirements for method transfer in its new draft guidance from 2015 on validation of analytical methods. This webinar will give a good understanding of USP and FDA requirements and provide recommendations and tools for effective implementation.
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System Suitability Testing for FDA and USP Compliance
System suitability testing (SST) is required by USP and FDA to check and ensure on-going performance of analytical systems and methods. Both USP and EP have chapters with recommendations for system suitability tests that are enforced by FDA and other agencies. Related chapters have been updated by USP and EP and they also answer the question as to how much a method can be changed without the need for revalidation. Also, the USP chapter <1058> makes a statement that SST can substitute an instrument's performance qualification, but not further guidelines are given. This webinar will give a good understanding of FDA and USP requirements for system suitability testing.
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Validation of Excel Spreadsheets for Regulated Environments: Step-by-Step
In this webinar on validation of excel spreadsheets, the participants will learn how to apply risk based validation to spreadsheet applications step-by-step. The webinar will also discuss what are the requirements for excel validation and how to implement them to comply with the regulations.
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GMP Compliance for Quality Control and Contract Laboratories
Even though CGMP regulations have been in place since long time, the large number of QC related 483's and warning letters demonstrate that companies have problems with up-to-date requirements and implementation. Quality control laboratories are considered high risk because after testing and approval, pharmaceutical drug products and APIs are released to the market without further check. That's the reason why FDA and other agencies put highest emphasis on inspections of QC and related contract laboratories.
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Validation and Use of Cloud Computing in FDA Regulated Environment
This webinar will give a good understanding of FDA and equivalent international requirements for cloud computing.
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Verification of Compendial Methods-USP <1226>-Why and How
This webinar on verification of compendial methods will give a good understanding of the revised USP Chapter &lt;1226&gt; and FDA requirements and also provide recommendations and tools for its effective implementation.
Recorded Session Get life time access for one participant with download option!

Understanding and Implementing USP 1058 - Analytical Instrument Qualification
This Analytical Instrument Qualification training will guide you through Understanding analytical instrument qualification from planning through all qualification phases until writing the qualification report.
Recorded Session Get life time access for one participant with download option!

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