Labcompliance On-line Audio Seminar
This seminar has been recorded and is
available on CD and for instant download. All reference material as
listed below and more is available on a special seminar website. The
website is regularly updated with most recent information. In case
there are questions related to the topic, they can be submitted
through a web form and will be answered by the speaker. For ordering
info
click here
To share this seminar info with your colleagues,
click here
On-line Audio Seminar 335
Understanding Quality by Design for the
Pharmaceutical Industry
Introduction to Principles, Regulatory
Activities and Industry Practices
Recorded, available with all reference material
at any time

While Quality by Design (QbD)
principles have widely
been used to advance product and process quality in
many industries, now
they also are increasingly adopted
by the Pharmaceutical industry for development and commercialization of
drugs to improve process efficiency and product quality. For
example the US FDA and the EU EMA are driving QbD principles through
common FDA/industry pilot programs and through incentives such as faster new
drug approvals. While several QbD based new drugs have already been approved the
majority of the industry is unsure what QbD really means and how to implement
it.
Key Questions related to QbD are
- What is QbD?
- What is the difference to conventional processes?
- Are there examples for the related terminology such as
Critical Process Parameters (CPP), Critical Product Attributes
(CPA) or Design Space?
- What are the be benefits for the industry?
- Is QbD required by regulations?
- Why is FDA so much interested in QbD?
- Why is risk assessment so important?
- How to define the design space?
- What are the elements of the QbD based drug development
process?
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:
- History and regulatory background
- FDA and EMA co-operation
- ICH Q8/Q9/Q10/Q11-Guidelines – The foundation for QbD
- Principles and key benefits for patients, industry and FDAs
- QbD elements and terminology
- Comparison with conventional processes
- Going through the QbD process and steps for drug development
- The role of risk assessment
- Defining the design space
- The right control strategy: Real time release testing vs.
end product testing
- monitoring and improvement
- Specific requirements for generic drugs
- FDA recommendations for submission
- Industry concerns and activities
And for easy and instant implementation:
download 10+ documents from special seminar website
- Checklist: Implementing Quality by Design in the
Pharmaceutical Industry
- Publications related to QbD in the pharmaceutical industry
(links)
- FDA presentations related to QbD in the pharmaceutical
industry (links)
- Industry
presentations related to QbD in the pharmaceutical industry
(links)
- Slides of the presentation as PPT
files to train others
- Script of the presentation
- All questions and answers from before,
during and after the seminar
Steps for QbD in Pharmaceutical Development

All steps are very well discussed in the seminar
Who should attend?
- Operation managers and staff
- 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
click here
just
click here
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, |