Labcompliance On-line Audio Seminar
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On-line Audio Seminar 296
Verification of
Compendial Methods according to the Revised USP Chapter
<1226>
Understand the
new risk based approach and get real world
case studies for testing
Recorded, available with all reference material
at any time

Compendial methods such as USP and EP standards are validated
by the organizations that have developed and published the method. The FDA
requires users of such methods to demonstrate the user's competence to
successfully run the method. For example, 21 CFR 211.194 (a) states: The
suitability of all testing methods used shall be verified under actual
conditions of use. However, the FDA does not give any further guidance
on what, when and how. And the first revision of USP <1226>
did not have specific recommendations. But FDA inspectors go out and write 483's
and warning letters related to <1226>. Now USP did come out with a new revision
using the risk based approach for the type and extent of testing. Because there
are no further guidelines
there are still
many questions.
Key Questions are:
- What are FDA and international
requirements for compendial methods?
- What and how much should be tested?
- How to aply the risk based approach?
- Is system suitability testing enough?
- Do all compendial routine methods require
verification?
- When could just system suitability testing be enough?
- Should we verify all performance
characteristics?
- How much can we deviate from the
compendial method without the need for a full revalidation?
- What to do if the compendial procedure
can not be verified?
- How frequently should compendial methods
be re-verified?
- What if our equipment was not included in
the USP method validation experiments
How does 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 the requirements for method verification and give
practical recommendations. After the seminar, an extensive list of
reference material like SOPs, real world case studies
for testing, worksheets, templates and
examples will help immediate and cost effective implementation.
During the interactive presentation you learn
about:
- FDA and international requirements for
verification of compendial methods
- Inspection and enforcement practices:
examples for recent FDA warning
letters
- The background and scope of USP <1226>
- What's new in the second revision?
- Compendial methods not requiring
verification
- The USP verification process
- USP <1226> requirements for
verification and testing
- Risk based approach for type and
extent of testing
- Performance characteristics for
verification testing: proven industry examples
- Acceptance criteria for testing
- How much can compendial methods be
changed
- Change vs. adjustment of compendial
methods
- Investigating non-performance: root cause
and corrective actions
- Documenting the verification experiments
and results
And for easy and instant implementation:
download 10+ documents from special seminar website
- SOPs:
- Verification of Compendial Methods
- Change vs. Adjustments of Compendial Methods
- Validation of Chromatographic Methods
- Checklist:
- Verification of Compendial Methods
- Validation of Analytical Methods and Procedures
- Case Studies; Verification of Compendial methods and
procedures
- AOAC Guide: How to Meet ISO 17025 Requirements for Method
Verification (link)
- Reference Article
- Validation of Standard Methods
- Validation of HPLC Methods
- Validation of analytical methods: review and procedures
- Recent FDA Warning Letters
and/or Inspectional observations related to verification
of compendial methods
- USP Presentation with test
examples: Verification of Compendial
Procedures
- Proposed revision of the USP <1226> (link)
- FDA Guidance
- Analytical procedures and methods validation
- ICH Guideline for the Industry
- Validation of Analytical Procedures: Definitions and
Methodology
Who should attend?
- Laboratory managers and staff
- Analysts
- QA managers and personnel
- Regulatory affairs
- Training departments
- Documentation department
Date, time and duration
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, 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.
Dr. 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 explined FDA'snext steps for Part 11
|
 |
Ludwig Huber
(right) in a panel discussion with FDA inspectors and
directors:
Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare, and
Nicholas Buhay, |