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 176
Transfer of Analytical Methods and
FDA Requirements, Strategies and Tools for
When validated methods are transferred between laboratories and sites, their
validated state should be maintained to ensure the same reliable results in the
receiving laboratory. Until recently there was specific FDA guidance on what
exactly is expected to maintain 'the validated state'. Now the FDA has released
an official guidance on how to conduct and document method transfer. The guide
has been developed for medicated feed assays but the principles can be applied
to other methods. The guide answers questions managers and lab analysts had on
what to do and how to conduct and document method transfer.
Key Questions are:
- Method transfer is easy, why should we go through a formal
- Are there any specific FDA requirements?
- Should the receiving laboratory do full revalidation?
- What should be tested in the receiving laboratory?
- What can go wrong during method transfer?
- Anything to care about for transfer to other sites?
- Are system suitability tests sufficient?
- How much can I change a transferred method without
- When can 'official' method transfer be omitted?
- What are the responsibilities of the transferring and
- How should we 'formally' document method transfer?
How does the this 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 and
checklist will help immediate and cost effective implementation.
During the interactive presentation you learn about:
- FDA and International regulations for method transfer
- Examples of FDA warning letters and how to avoid them
- The new FDA Guidance on method transfer.
- Developing a strategy for analytical method transfer
- Developing an SOP for method transfer
- Responsibilities of the transferring and receiving
- Developing a transfer plan: contents and approval
- Method transfer options
- Types of method transfer and testing
- The importance of acceptance criteria
- Conducting comparative studies
- Statistical evaluating transfer results
- Most likely failures during method transfer
- Criteria for transfer waiver (omission of formal transfer)
- Method transfer protocol and summary report
And for easy and instant implementation:
download 10+ documents from special seminar website
- Master Plan: - Transfer of Analytical Methods and procedures
- Verification of Compendial Methods
- Transfer of Analytical Methods
- Validation of Analytical Methods and Procedures
- Laboratory Audits
- Reference Articles
- Validation of Analytical Methods: Review and Strategy
- 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:
- Analytical Procedures and Methods Validation
- FDA Industry Guidance: Protocol for the Conduct of Method
Transfer for Type C Medicated Feed Assay Methods
- 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
Who should attend?
- Everybody involved in method transfer
- QA managers and personnel
- Analysts and lab managers
- Validation specialists
- Training departments
- Documentation department
How to order
Replaced by the more recent seminar
Analytical Procedures According to the New USP
With SOPs, templates and examples
for easy implementation
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,