Labcompliance On-line Audio Seminar
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available on CD and for instant download. All reference material as
listed below and more is available on a special seminar website. The
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On-line Audio Seminar 337
Impact of Quality by Design on the
Analytical Laboratory
Learn through the example from development
and validation of analytical procedures
Recorded, available with all reference material
at any time
Even though the Quality-by-Design (QbD) principle is well known in the industry
to improve the quality of data and efficiency of operations, it is a new concept
for analytical laboratories. This is changing since regulatory agencies such as
the US FDA and European counterparts are heavily promoting and supporting QbD.
This presentation gives an overview of the principles and regulatory
requirements. In addition we will discuss benefits for laboratories and clients,
and we will go through the process and entire steps of QbD in laboratories using
the “Development and Validation of Analytical Methods” as an example. Attendees
will get a good understanding on what QbD is and how to implement if for
laboratories..
Key Questions related to quality-by-design for
laboratories:
- What are the key applications of QbD for Analytical
Laboratories
- What are the advantages for the laboratories and customers?
- What is the situation in the industry?
- What is the process of analytical QbD
- Are there examples for the analytical target profile (ATP)
- Method design and development
- How to define design space and method operational ranges
- Is the validation different from ICH Q2?
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:
- Introduction to analytical QbD
- Industry initiatives for QbD in analytical laboratories
- Applications of QbD for Analytical Laboratories
- Traditional validation vs. QbD validation
- Definitions: Analytical Target Profile (ATP), Critical
Method Parameters (CMP),
Critical Method Attributes (CMA), Method Operational Design
Range (MODR)
- The 6-stage process of analytical QbD
- Analytical target profile (ATP)
- Method design and development
- Sources of variability impacting critical method attributes
- Risk assessment to determine critical method variables
- Multivariate Design of Experiments (DoE)
- Design space and method operational ranges
- Validation / qualification
- Control strategy
- Continuous improvement
- Advantages of QbD for laboratories, Industry concerns
- EMA/FDA answers to frequently asked questions
And for easy and instant implementation:
download 10+ documents from special seminar website
- Master plan - Template and examples: Development and
Validation of Analytical Methods through QbD
- SOP: Development and Validation of
Analytical Methods through Quality by
Design
- Templates
- Analytical Target Profile for selected HPLC methods
- Design space for selected HPLC methods
- Risk Prioritization Matrix for Quality by Design based Method
Validation
- Five industry presentations and case studies related to
- QbD for method development and validation
- QbD for dissolution testing
- Eight Reference Articles
- QbD for Better Method Validation and Transfer
(link)
- A Quality by Design approach to investigate tablet dissolution
shift
upon accelerated stability by multivariate methods
- 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:
- QbD Considerations for Analytical Methods - FDA Perspective
- Quality by Design Approaches to Analytical Methods - FDA
Perspective
(2011)
- ICH Guidelines for the Industry
- Validation of Analytical Procedures: Text and
methodology (ICH Q2)
- PowerPoint Presentation
- Script
- All questions and answers from before,
during and after the seminar
Six step process for method development and validation by QbD
QbD starts with defining the Analytical Target Profile
The seminar explains all six steps using examples.
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.-
|
Please forward to your colleagues, just
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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 and many other conferences
and has been awarded as IVT's '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, |