Labcompliance On-line Audio Seminar
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On-line Audio Seminar 382
Transfer of Analytical Methods According to New FDA, USP and
EU-GMP Guidelines
With SOPs, templates and examples for easy
implementation
Recorded, available with all reference material
at any time7

Since USP released the first version of chapter <1224> for transfer of
analytical procedures several other organization also developed guidelines on
the same topic with more details on how to conduct comparative testing and on
acceptance criteria. For example, ISPE and WHO published guidelines as part of
their technology transfer initiatives, the new EU GMP Chapter 6 gives some
specific advice on acceptance criteria and also the most recent FDA Method
Validation Guidance includes a related chapter with information on what
parameters to test. For example, one of FDA's recommendations is to include
forced degradation test samples for comparative testing of stability indicating
methods. So many guidelines with lots of different requirements raise a lot of
questions for pharmaceutical laboratories
Key Questions are:
- Why became analytical method transfer so important?
- What is the difference between the various guidelines?
- Which ones are must requirements for the FDA/EMA
- Which requirements are cited in FDA warning letters or
483's?
- Are there any detailed recommendations for comparative
testing, such as number of tests or acceptance criteria?
- The USP chapter suggests to base
extent of testing on risk. How to do this?
- What must be
tested in the receiving laboratory?
- Which of the guidelines describe tests required for method
transfer
- What are most common mistakes during
method transfer?
- Is there are step-by-step
procedure that satisfies FDA inspectors?
- Anything special to care about for
transferring methods to other sites?
- When are system suitability tests
sufficient?
- How much can I change a transferred
method without revalidation?
- I want to transfer our standard method to
ultra 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,
templates and
a checklist will help immediate and cost
effective implementation.
During the interactive presentation you learn
about:
- Current FDA and International
expectations
for method transfer
- Examples of FDA warning letters and how
to avoid them
- Going through the details of various guidelines
- The FDA industry guidance
on method transfer
- The method transfer chapter in the new FDA guide method
validation guide
- The method transfer chapter of the WHO technology
transfer document
- The method transfer chapter of the ISPE technology transfer
document
- The updated USP chapter <1224>
- The new EU GMP chapter 6.
- Common requirements of all guidelines
- Good practice recommendations from individual guides
- Most significant differences
- Recommended approach for cost-effective and compliant
transfer
- Going through a step-by-step procedure for method transfer
- Responsibilities of the transferring and
receiving laboratory
- Developing a transfer plan and a
pre-approval protocol
- Conducting comparative transfer
studies: what, how much
- Criteria and approaches for risk based testing: what, when,
how much?
- The importance and selection
of acceptance criteria
- Method transfer from standard HPLC to
UHPLC
- 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
- Slides as PowerPoint Presentation, Script, Questions and
Answers
- 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
- Checklist
- Transfer of Analytical Methods and
Procedures
- Example
- Preapproval protocol
- 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
- Analytical Method Transfer (with three case studies)
- Analytical Methods Validation, A Regulatory Perspective
- FDA Guidance and Policy:
- Analytical Procedures and Methods Validation 2015
- ICH Guidelines for the Industry
- Text on Validation of Analytical Procedures
- Validation of Analytical Procedures: Methodology
Example: Acceptance Criteria for Comparative Testing of
Quantitative Impurities

Acceptance criteria for comparative testing are most important for method
transfer. The seminar discusses several examples.
Who should attend?
- Everybody involved in method transfer
- QA managers and personnel
- Analysts and lab managers
- Validation specialists
- Training departments
- Documentation department
- Consultants
Date and
time
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.-

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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, CFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health
agencies.
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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.
r. 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
|