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

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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 330

Understanding the 'New' FDA Guide for Validation of Bioanalytical Methods

With SOPs, templates and examples for easy implementation

Recorded, available with all reference material at any time

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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 'New' FDA Guidance from September 2013 ensures reliability, consistency and accuracy of bioanalytical data. But because of the difficult nature of the analysis there are still many questions.

Key Questions related to Bioanalytical Method Validation are:

  • What are FDA and international requirements?
  • What is the difference to the existing guidances from FDA 2001 and EMA 2011
  • What exactly are the expectations of inspectors?
  • What is the scope of the guidance: small vs. large molecules, GLP  vs GCP?
  • At what stage of the drug development should the method being validated?
  • What parameters should be validated and how should they be tested?
  • Which acceptance limits MUST be defined for small and large molecules?
  • How to validate small and large molecules?
  • When are stability indicating methods important?
  • How should we document raw and source data?
  • For how long should we archive validation documentation?
  • What is 'incurred sample reanalysis?'
  • 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?

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 recent Crystal City and FDA/Industry conference reports
  • Comparing the FDA guidances from 2001 and 2013
  • Comparing the New FDA guidance with the guidance from EMA
  • Phased approach for validation during drug development
  • Scope of bioanalytical method validation: small vs. large molecules, GLP& GCP
  • Development of a master plan and SOP for validation
  • Defining validation parameters, acceptance limits and tests for small and large molecules
  • Validation of methods based on chromatography and Ligand Binding Assays
  • Working with QC samples for quantitative results
  • Purpose and requirement for Incurred Sample Reanalysis (ISR)
  • Conducting an Incurred Sample Reanalysis
  • Requirements for system suitability testing
  • Special considerations for endogenous compounds, biomarkers and diagnostic kits
  • Documentation for the FDA and other agencies

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

  • PowerPoint Presentation
  • Script
  • SOPs
    - Validation of Bioanalytical Methods
    - Transfer of Analytical Methods
    - Change versus Adjustment of Analytical 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
    - Key Elements of Bioanalytical Method Validation for Macromolecules
    (abstract, link)
    - Bioanalytical Method Development –Determination of Drugs in Biological Fluids
  • FDA presentation: Documentation of Bioanalytical Data and Reports: U.S. Food and Drug Administration Perspective, M. Skelly, FDA CDER
  • FDA Guidance and Policy:
    - Bioanalytical Method Validation (draft 2013)
  • EMA Guidance and Policy:
    - Bioanalytical Method Validation
  • * GCP Inspectors Working Group: Reflection paper on guidance for laboratories that perform the analysis or evaluation of clinical trial samples  (2010) Draft  (link)
  • Warning letters and/or Inspectional observations related to 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

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.