Labcompliance On-line Audio Seminar
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available on CD and for instant download. All reference material as
listed below and more is available on a special seminar website. The
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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

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.-

|
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:
- Study the printed slide material
- Watch the slides on a computer
- Watch the slides on a video screen in a seminar room
- 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.
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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.