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
click here.
On-line Audio Seminar 231
FDA Compliant Transfer
of Analytical Methods
Prepare your Lab for the
NEW USP General Chapter
Recorded

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. So far there have not been
official guidance on what exactly is expected to maintain 'the validated state'.
Now the USP is preparing for a general chapter and 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. Now it is a good time to learn how to conduct and document
method transfer for FDA compliance. However, transferring analytical methods
raises a number of questions
Key Questions are:
- Method transfer is easy, why should we go
through a formal process?
- Are there any specific FDA requirements?
- Are there examples for FDA warning
letters?
- What are recommendations from USP?
- Should the receiving laboratory do full
revalidation?
- What should be tested in the receiving
laboratory?
- What are most common mistakes during
method transfer?
- Anything special to care about for
transfer to other sites?
- When are are system suitability tests
sufficient?
- How much can I change a transferred
method without revalidation?
- I want to transfer our standard method to
hi-speed HPLC. What to do?
- When can 'official' method transfer be
omitted?
- What to do if acceptance criteria are not
met? Should we follow a formal OOS?
- What are the responsibilities of the
transferring and receiving laboratories
- 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.
- The proposal for a new USP chapter
- Developing a strategy for analytical
method transfer
- Developing an SOP for method transfer
- Responsibilities of the transferring and
receiving laboratory
- Developing a transfer plan: contents and
approval
- Types of method transfer and testing
- The importance of acceptance criteria
- Conducting comparative studies
- Statistical evaluation of transfer
results
- Dealing with technology transfer:
validation requirements, regulatory notification.
- Method transfer from standard HPLC to
(ultra)fast HPLC
- Most likely failures during method
transfer
- Handling deviations from documented
acceptance criteria
- 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 template and examples: -
Transfer of Analytical Methods and procedures
- SOPs
- Validation of Chromatographic Methods
- Transfer of Analytical Methods
- Change versus Adjustment of Analytical Methods
- Case Study: Analytical Method Transfer
Protocol
- Templates/Checklist/Worksheet:
- 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)
- USP Stimuli Paper: Transfer of Analytical
Procedures: A Proposal for a New General Information Chapter (LInk)
- USP Stimuli Paper: Transfer of HPLC
Procedures to suitable Columns of Reduced Dimensions and
Particle Sizes (Link)
- FDA Warning-letters and/or Inspectional
observations related to method transfer
- 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
- FDA Guidance and Policy:
- Analytical Procedures and Methods Validation
- 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
- Consultants
Date, time and duration
Order at any time, replay at any time.
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.
|
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.