Labcompliance On-line Audio Seminar
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On-line Audio Seminar 360
New Guidelines and Trends in Method
Validation and Transfer
Comply with new FDA, EMA, USP and Industry
Guidelines
Recorded, available with all reference material
at any time

Method validation and transfer is receiving highest attention at FDA and
industry. For example, several new important guidelines have been released from
regulatory bodies and industry task forces for method development, validation
and transfer. They include new FDA guides for method validation with elements of
quality by design and for bioanalytical method validation, a new GMP chapter
from Europe for method transfer, two new technical report from PDA on the
lifecycle approach for analytical method validation of biotechnology products
and several USP chapters with impact on revalidation and statistical evaluation.
So the industry is confused about the many guidelines and is looking for expert
advice. This presentation will discuss critical requirements and give
recommendations on how to effectively implement them for (bio)pharmaceutical
research, development and QC laboratories.
Key Questions related to new developments on method
validation
- Why is it that there are so many new guidelines?
- What are the key points of each of the guideline
- What is the purpose of new planned USP chapters 220, 1200,
1210 and 1220
- Which of the new guidelines should be implemented
- What are the key recommendation on how to implement the
guidelines
- What are the common requirements?
- Are there any requirements contradictory
- How do the guides compare with ICH Q2?
- Is ICH still required and is it still good enough
- Do we need to implement quality by design
- What are the benefits of the integrated lifecycle for
design, development, validation
- Which development studies must conducted under GMP
conditions?
- What are USP's plan to replace chapters 1224, 1225 and 1226?
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 an overview and give practical
recommendations. After the seminar, an extensive list of reference
material like SOPs, test scripts, templates and examples will help
immediate and cost effective implementation. The seminar lasts one
hour and will be conducted over the phone and supported by the
Internet.
During the interactive presentation you learn
about:
- Limitations of the current regulations and guidelines for
method validation
- General trends in method validation, method transfer and
verification
- FDA and international enforcement and inspection practices:
- warning letter examples
- USP strategy for analytical methods: new chapters 1220 and
220
- Going through the new guidelines and trends: scope and key
points
- FDA Guidance: Analytical procedures and methods for drugs and
biologics
- FDA guidance: Bioanalytical method validation
- USP Chapter <1210>: Statistical tools for procedure validation
- USP Chapter <1200>: Requirements for compendial validation
- USP PF Stimuli paper: Lifecycle management of analytical
procedures;
Method development, procedure performance qualification, and
procedure for performance verification (proposal for new 1220)
- EU GMP Chapter 6, Quality Control: Technical transfer of
testing methods
- PDA Technical Report 57 and 57-2: Analytical method
development and
qualification for biotechnology products
- Comparison with ICH Q2 and USP 1225
- Recommendations for what to implement and what to forget
about
- "Must do" for FDA/EU inspections
And for easy and instant implementation:
download 10+ documents from special seminar website
- 70 page primer: Validation of Analytical Methods: Author Dr.
Ludwig Huber
Good overview of basic validation, verification and transfer
principles
- SOPs
- Validation of Analytical Methods
- Verification of Compendial Methods
- Transfer of analytical methods
- Template/Checklist:
- Validation of Analytical Methods according to the FDA
Guidance 2014
- Transfer of Analytical Methods and
Procedures
- Example
- Validation Report for Analytical Methods
- USP Stimuli Article (link)
- Lifecycle Management of Analytical Procedures: Method
Development, Procedure Performance, Qualification, and Procedure
Performance Verification
- New USP draft Chapters (links)
- <1200>: Requirements for compendial validation
- <1210>: Statistical tools for procedure validation
- USP PF Stimuli paper: Lifecycle management of analytical
procedures;
Method development, procedure performance qualification, and
procedure for performance verification (proposal for new <1220
>)
- Five Warning letters and/or Inspectional observations
related to method validation
- FDA Guidance and Policy:
- Bioanalytical Method Validation (draft 2013)
- Analytical Procedures and Methods Validation (draft 2014)
- FDA presentations on method validation
- Analytical Methods Validation, A Regulatory Perspective
- ICH Guidelines for the Industry Q2 (R1)
- Text and Methodology on Validation of Analytical Procedures
- Slides of the presentation as PPT
files to train others
- All questions and answers from before,
during and after the seminar
Who should attend?
- Laboratory managers and staff
- Analysts
- QA managers and personnel
- Regulatory affairs
- Training departments
- Documentation department
- Consultants
- Validation specialists
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.-

|
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.
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
|
 |
Ludwig Huber
(right) in a panel discussion with FDA inspectors and
directors:
Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare, and
Nicholas Buhay, |