Labcompliance On-line Audio Seminar
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On-line Audio Seminar 325
Quality by Design (QbD) for Development
and Validation of Analytical Methods
Apply modern Lifecycle Management
Principles for Analytical Methods
Recorded, available with all reference material
at any time

Using the QbD approach for development and validation will result in more robust
analytical methods. Advantages are easier method
method transfer, longer revalidation cycles and fewer or no methods specific
Out-of-Specification situations when used in routine. In addition FDA, USP
and international agencies promote the QbD approach because it is expected that
such performance based routine methods can be changed within the analytical
target profile (ATP) without regulatory resubmission and approval. Because
there is no or little experience with the QbD approach for analytical
methods the industry
has many questions.
Key Questions related to Quality by Design and Method
Validation
- What does it mean: Quality by design?
- What is the regulatory background: ICH, FDA, USP, Europe,
Asia, PIC/S?
- Where and how is the industry already using the QbD
approach?
- Why should we change the way we develop and validate
methods?
- What is the main difference to the current validation
approach based on ICH Q2?
- What are the advantages of QbD for method validation and
routine use?
- How to apply risk assessment for method validation?
- What are the drawbacks, if there are any?
- What are the most cost-effective steps of the QbD approach?
- How to define the 'design space'?
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.
During the interactive presentation you learn
about:
- General principles and key benefits of QbD
- Regulatory background and trends: FDA, ICH Q8/9/10
- Reasons for changing the way we validate methods
- Current applications of QbD in the pharmaceutical industry
- The Application of QbD for analytical methods
- Comparison of the QbD process with ICH Q2 and USP <1225>
- Benefits for method transfer and routine use
- Using the lifecycle approach for method design, development
and validation
- Using the risk assessment prioritization matrix to select
the test parameters
- The timeline for method design, validation and verification
- Using the method in the routine: re-verification and change
control
- Documentation requirements
- Defining the Analytical Target Profile (ATP) and design
space
- Case studies
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: Development and
Validation of Analytical Methods through QbD
- SOPs
- Development and Validation of Analytical Methods
through Quality by Design
- Transfer of Analytical Methods
- Case Study: Analytical Method Transfer
Protocol
- Checklist
- Transfer of Analytical Methods and
Procedures
- Templates
- Analytical Target Profile for selected HPLC methods
- Design space for selected HPLC methods
- Risk Prioritization Matrix for Quality by Design based Method
Validation
- Reference Articles
- QbD for Better Method Validation and Transfer
(link)
- Quality by Design Systematic Chromatographic Method
Development
(Poster, link)
- A Lifecycle Concept for Pharmaceutical Analysis (link)
- Quality by Design for Analytical Methods: Implications for
Method Validation and Transfer (link)
- Analytical Quality by Design (AQbD) in Pharmaceutical
Development (link)
-
- FDA Presentation:
- Regulatory considerations of the QbD approach for analytical
methods
- FDA Update on Implementation of Quality by Design (QbD)
- FDA Warning-letters related to method
validation
- ICH Guidelines for the Industry
- Validation of Analytical Procedures: Text and
methodology
- ICH Q8, Q9, Q10
QbD Steps for Analytical Method Development and Validation

Who should attend?
- Laboratory managers and staff
- Analysts
- QA managers and personnel
- Regulatory affairs
- Training departments
- Documentation department
- Consultants
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.
. 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, |