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 336
Validation of Analytical Methods according
to the New FDA Guidance
Understanding FDA's New Lifecycle Approach
for Method Validation
Recorded, available with all reference material
at any time

Recently the FDA has released a new comprehensive guidance for validation of
analytical methods. The guidance applies the modern integrated lifecycle
approach with related new requirements for using quality-by-design components,
risk assessment, design space and continuous improvement. The guidance will
significantly change the way how FDA regulated methods will be developed,
validated and used. Because of the novelty of some of the concepts the industry
has difficulties to understand and implement the guidance.
Key Questions related to the new FDA method validation
guidance are:
- What are the differences to the old guidance?
- What is the scope of the new guidance, when does it apply?
- How does the guide compare with ICH Q2?
- How to apply the integrated lifecycle?
- How to apply risk assessment?
- What are the recommended validation parameters, tests and
acceptance criteria?
- Which QbD components does the guide recommend?
- What to test for alternative analytical methods?
- Should validation experiments be conducted under GMP
conditions?
- Which development studies should be submitted to the FDA?
- What exactly are the expectations for documentation?
- How does the FDA verify submitted methods?
- How to get re-approval when we change approved methods?
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 an overview and give practical
recommendations. After the seminar, an extensive list of reference
material like SOPs, test scripts, templates and examples will help
immediate and cost effective implementation. The seminar lasts one
hour and will be conducted over the phone and supported by the
Internet.
During the interactive presentation you learn
about:
- Scope and content of the guidance
- Going through validation parameters, tests, and acceptance
criteria
- Comparison with ICH Q2
- Lifecycle management of analytical procedures
- Periodic review and revalidation
- Analytical method comparability studies for alternative
analytical procedures
- Analytical method transfer studies
- Development experiments that should be conducted under GMP
conditions
- Application of QbD components: design space, multivariate
experiments, risk assessment
- Documentation requirements
- Verification of submitted methods at the FDA
- Reporting post-marketing changes to an approved method
And for easy and instant implementation:
download 10+ documents from special seminar website
- 70 page primer: Validation of Analytical Methods
- SOPs
- Validation of Analytical Methods
- Verification of Compendial Methods
- Change versus Adjustment of Compendial Methods
- Template/Checklist:
- Validation of Analytical Methods according to the FDA
Guidance 2014
- Example
- Validation Report for Analytical Methods
- USP Stimuli Article (link)
- Lifecycle Management of Analytical Procedures: Method
Development, Procedure Performance, Qualification, and Procedure
Performance Verification
- Three Reference Articles
- Five Warning letters and/or Inspectional observations
related to method validation
- FDA Guidance and Policy:
- Bioanalytical Method Validation (draft 2013)
- Analytical Procedures and Methods Validation (draft 2014)
- FDA presentations on method validation
- Analytical Methods Validation, A Regulatory Perspective
- ICH Guidelines for the Industry Q2 (R1)
- Text and Methodology on Validation of Analytical Procedures
- Slides of the presentation as PPT
files to train others
- Script of the presentation
- All questions and answers from before,
during and after the seminar
What's New?

Attend the seminar to learn about all details on what's new
compared to the 14 year old existing guide
Who should attend?
- Laboratory managers and staff
- Analysts
- QA managers and personnel
- Regulatory affairs
- Training departments
- Documentation department
- Consultants
- Validation specialists
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.-

|
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.
|
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, |