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Analytical method validation - A Regulatory Perspective

Verification of Compendial Procedures

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


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
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On-line Audio Seminar 342

Effective Validation of Analytical Methods for GLP and Clinical Studies

Learn how to design, prepare, conduct and document for FDA Compliance

Recorded, available with all reference material at any time

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Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. This is important for all methods used in all FDA and equivalent international environments. While the USP and ICH guidelines are well accepted as standards for validation of routine analytical methods used in quality control development laboratories are unsure on what and how much to validate. However FDA inspectors go out and write inspectional observations and warning letters, for example: "The Study Director failed to ensure that analytical methods used in nonclinical laboratory studies were accurate.". So there are many questions.

Key Questions related to Method Validation for GLP and Clinical Studies

  • What are FDA and international requirements?
  • What exactly are the expectations of inspectors?
  • What parameters should be validated at which phase?
  • Which acceptance criteria MUST be defined and what are acceptance limits?
  • What information should be included in regulatory submissions?
  • And what should be available during inspections?
  • What is the role of quality assurance in early development phases?
  • How to document method validation for the FDA?
  • When we change the 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 references with request for method validation used in GLP and GCP studies
  • European and international references
  • Examples of warning letters and how to avoid them
  • The concept and implementation of validation by development phases
  • The purpose of validation and use of methods in different phases
  • Parameters that should be tested for preclinical studies and for clinical studies phases I, II and III.
  • Defining test conditions and acceptance limits for each phase
  • Using the risk based approach for short and long term studies
  • Seven most common method validation pitfalls and how to avoid them
  • Using software for automated method validation
  • Sharing best practices
  • Documentation for the FDA and for other agencies

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

  • 70 page primer: Validation of Analytical Methods
  • SOP: Validation of Bioanalytical Methods
  • SOP: Validation of Chromatographic Methods
  • SOP: Validation of Stability Indicating Methods
  • SOP: Change versus Adjustment of Compendial Methods
  • Template/Checklist: Validation of Analytical Methods
  • Example: Detailed Validation Report
  • Reference Article: Validation of Analytical Methods: Review and Strategy
  • Method Transfer Master Template and Examples
  • Five Warning letters and/or Inspectional observations related to method validation, includes examples from GLP studies
  • FDA Guidance : Bioanalytical Method Validation
  • FDA Guidance: Analytical Procedures and Methods Validation (draft)
  • EMA Guideline on Bioanalytical Method Validation
  • FDA presentation: Analytical Methods Validation, A Regulatory Perspective
  • ICH Guidelines for the Industry Q2 (R1)
    - Text and Methodology on Validation of Analytical Procedures

Most interesting for seminar attendees will be recommendations on what to test for which development phase. The table will be filled with examples.

Who should attend?

  • (Bio) Pharmaceutical and API Industry
  • Clinical Research Organizations
  • GLP development laboratories
  • Study directors
  • QA managers and personnel
  • Analysts and lab managers
  • Validation specialists
  • Training departments
  • Documentation department
  • Consultants

Date, time and duration

Recorded seminar, available at any time with all reference material

How to order

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

Recorded seminar - Web Download

  • 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.

Ludwig Huber in Panel Discussions with FDA Officials

George Smith, FDA's national Part11 expert, at a panel discussion with Ludwig Huber during an IVT conference

Smith and Huber discussed and answered questions about computer system validation and e-records.
Ludwig Huber (right) and John Murray, FDA's Computer Validation Expert, (left), speaking at the IVT Computer System Validation Conference.
Mr. Murray explained FDA's next steps for Part 11

Ludwig Huber (right) in a panel discussion with FDA inspectors and directors:
 Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare,  and Nicholas Buhay,



Ludwig Huber (right) in a panel discussion with FDA inspectors and directors:
 Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare,  and Nicholas Buhay,