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Learn from FDA Warning Letters what inspectors look for and what mistakes other companies make so you can avoid them

We have several forms that help to implement the procedure consistently and effectively.


Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for instant download. All reference material as listed below and more is available on a special seminar website. The website is regularly updated with most recent information. In case there are questions related to the topic, they can be submitted through a web form and will be answered by the speaker. For ordering info click here)

On-line Audio Seminar 208

Bioanalytical Methods Validation

Conduct and Document for Efficiency and FDA and EMEA Compliance


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Analyzing biological fluids is one on the most difficult tasks in analytical laboratories. Most challenging are interferences from matrices and decomposition products combined with low concentrations of analytes. Correct validation of bioanalytical methods according to recent FDA and industry recommendations ensures reliability, consistency and accuracy of bioanalytical data. But because of the difficult nature of the analysis there are many questions.

Key Questions related to Bioanalytical Method Validation are:

  • What are FDA and international requirements?
  • What exactly are the expectations of inspectors?
  • At what stage of the drug development should the method being analyzed?
  • What parameters should be validated?
  • Which acceptance limits MUST be defined?
  • How should we document raw and source data?
  • For how long should we archive validation documentation?
  • What information should be included in regulatory submissions?
  • I want to transfer a method from development to routine lab, do we need to revalidate?
  • We want to transfer to an other site, do we need to revalidate?
  • How to document bioanalytical method validation for the FDA?
  • We have slightly changed our method, should we revalidate?
  • We use software for automated method validation, should it be Part 11 compliant?

How does the audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, the speaker will present strategies and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • FDA regulations and guidelines
  • Learning from the Crystal City FDA/Industry conference report
  • Phased approach for validation during drug development
  • Logistics of validation
  • Development of a master plan and SOP for validation
  • Preparation and use of reference standards and equipment
  • Defining parameters and acceptance limits
  • Defining validation experiments
  • Documenting and archiving raw and source data
  • Considerations for Microbiological and Ligand-binding Assays
  • Working with QC samples for quantitative results
  • To revalidate or not after method changes
  • Transferring and using the method to routine
  • Using computers for automated method validation
  • Documentation for the FDA and other agencies

And for easy and instant implementation:
download 10+ documents from special seminar website

  • SOPs
    - Validation of Bioanalytical Methods
    - Transfer of Analytical Methods
    - Change versus Adjustment of Compendial Methods
    - Recording of GLP Raw Data (electronic and paper)
  • Checklist: - Validation of Bioanalytical Methods
  • Master Plan Template with Examples: Validation of Bioanalytical Methods
  • Reference Articles (Links)
    - Workshop/conference Report - Quantitative Bioanalytical Methods Validation and
       Implementation: Best Practices for Chromatographic and Ligand Binding Assays
    - The History of Bioanalytical Method Validation and Regulation
    - Application of confidence intervals to bioanalytical method validation
    - Adjusting Conditions for a Routine Reversed-Phase HPLC Assay,
      Part II: Changing Separation Conditions (link)
  • FDA presentation: Documentation of Bioanalytical Data and Reports: U.S. Food and Drug Administration Perspective, M. Skelly, FDA CDER
  • Warning letters and/or Inspectional observations related to method validation
  • FDA Guidance and Policy:
    - Bioanalytical Method Validation

Who should attend?

  • Managers and analysts in bioanalytical laboratories
  • Managers and analysts in forensic and toxicological laboratories
  • QA managers and personnel
  • Validation specialists
  • Training departments
  • Documentation department
  • Consultants

How to order

Pick one of the options in the table that fits your needs. 

Recorded seminar - Web download 'Site' offer

  • Multiple persons - single site
  • Learn at your desk, meet in a seminar or conference room or share the audio file and reference material at your site.
  • Order includes all reference material.

US$ 399.-
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Recorded seminar - CD

  • Get the CD in your mail
  • Order includes all reference material.

US$ 399.-
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Special offer for Labcompliance Usersclub Members
Recorded Seminar- CD or Web download.

  • Order includes all reference material.
  • for Usersclub information and registration, click here

US$ 299.-
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About audio seminars


Online audio seminars are presented over the phone. During the live presentation attendees can:

  1. Study the printed slide material
  2. Watch the slides on a computer
  3. Watch the slides on a video screen in a seminar room
  4. Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been conducting over 300 web and audio or video based seminars since 15 years and and he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health agencies.

Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.

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 visited FDA in Rockville, VA, and participated in panel discussions with FDA professionals. For feedback from attendees of seminars and  for other information on Dr. Ludwig Huber, click here.