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
On-line Audio Seminar 190
Validation of Analytical Methods and
Conduct and Document for Efficiency and
FDA, USP/EP and ISO 17025 Compliance
Analytical methods should be validated to ensure reliability, consistency and
accuracy of analytical data. Method validation has been a requirement of FDA and
international regulations and accreditation standards such as ISO 17025 since
many years. Most often the theory is well understood but there are many
questions when validation experiments are designed, conducted, and documented.
Key Questions related to Analytical Method Validation are:
- What are FDA and international requirements?
- What exactly are the expectations of inspectors?
- What are requirements of ISO 17025?
- What parameters should be validated?
- Which acceptance criteria MUST be defined and are acceptance
- Should standard and compendial methods be validated?
- Should we re-write compendial methods in SOP format?
- How to validate bio-analytical methods?
- What is the difference between accuracy and recovery?
- What information should be included in regulatory
- 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
- How to document method validation for the FDA?
- We have 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
During the interactive presentation you learn about:
- FDA regulations and guidelines
- Examples of warning letters and how to avoid them
- Requirements if ISO 17025
- Developing an SOP for method validation
- Development of a validation plan
- Defining parameters and acceptance limits
- Validation of standard methods
- To revalidate or not after method changes
- Transferring a method to routine
- Using software for automated method validation
- Documentation for the FDA, other agencies and for ISO 17025
And for easy and instant implementation:
download 10+ documents from special seminar website
- Validation of Analytical Methods
- Validation of Chromatographic Methods
- Transfer of Analytical Methods
- Verification of Compendial Methods
- Change versus Adjustment of Compendial Methods
- Validation of Analytical Methods
- Laboratory Audits
- Reference Articles
- Validation of Analytical Methods: Review and Strategy
- Validation of HPLC methods
- Evaluation and Validation of Standard Methods
- Adjusting Conditions for a Routine Reversed-Phase HPLC Assay,
Part II: Changing Separation Conditions (link)
- Five Warning letters and/or Inspectional observations
related to method validation
- FDA Guidance and Policy:
- Requesting Methods Validation for Abbreviated New Drug
- Bioanalytical Method Validation
- Analytical Procedures and Methods Validation
- FDA presentations on method validation
- How Much Can You Change An Official Method Before It Isn‘t The
Official Method Anymore?
- Analytical Methods Validation, A Regulatory Perspective
- ICH Guidelines for the Industry
- Text on Validation of Analytical Procedures
- Validation of Analytical Procedures: Methodology
- Eurachem: The Fitness for Purpose of Analytical Methods, 70
Who should attend?
- QA managers and personnel
- Analysts and lab managers
- Validation specialists
- Training departments
- Documentation department
Date, time and duration
Thursday, February 28, 2008
North America: ET 11 a.m. CT 10 a.m. PT 8 a.m., Europe: CET 5
Check: www.timeanddate.com/worldclock/ for you local time.
The seminar will last one our
How to order
Replaced by the more recent seminar
Validation of Analytical Methods
Conduct and Document for Efficiency
and FDA, USP/EP and ISO 17025 Compliance
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
||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,