Labcompliance Video Seminar 106
Video clips are recorded and imbedded in PowerPoint presentation
slides. This allows highest flexibility. For example slides and
clips can be skipped or replayed several times. The PowerPoint
presentation with video clips come on a CD or as web download.
Reference material such as 10+ best practice documents can be
downloaded from a password protected website. The site and its
updates can be accessed for two years.
Video Seminar 106
Validation of Analytical Methods and
Design, Conduct and Document for Efficiency
With Dr. Ludwig Huber
Analytical methods should validated to ensure reliability, consistency and and
accuracy of analytical data. Method validation has been a requirement of FDA and
international regulations 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 parameters should be validated?
- Which acceptance criteria MUST be defined and are acceptance
- Should standard 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
- Developing an SOP for method validation
- Development of a validation plan
- Defining parameters and acceptance limits
- Validation of standard methods
- Change control and revalidation
- Transferring a method to routine
- Using software for automated method validation
- Documentation for the FDA and other agencies
And for easy and instant implementation:
download 10+ documents from special seminar website
- Validation of Chromatographic Methods
- Transfer of Analytical 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
Cost and Ordering
Video seminar - Web download
- Download the video presentation from a password protected website
(approx. 150 Mbytes)
- Order includes all reference material.
- Share the video and all reference material at your site
Video seminar - CD
- Get the CD in your mail
- Order includes all reference material.
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,