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 268
FDA Compliance for Biopharmaceutical
Laboratories
Become familiar with FDA regulations and
get tool kits for implementation
Recorded, available with the reference material
at any time

There is a clear trend In the pharmaceutical industry from small to large
molecule based drugs. With the move of drugs from research to development and
manufacturing compliance becomes more and more important. Scientists and and
analysts working in biopharmaceutical laboratories should be aware of
specific requirements . US and most international countries have regulations
with specific sections for laboratories. However, regulations only tell you what
to do but not how to implement. So there are many questions.
Key Questions related to Regulated Biopharmaceutical are:
- What are the most important FDA and international
regulations and guidelines?
- When in drug product developments does each regulation
apply?
- Is drug discovery regulated?
- What are the key differences between regulated and
non-regulated laboratories?
- Which procedures do we need?
- Which laboratory records should be retained for how long?
- What and how to validate methods and qualify equiment
- How to most effectively implement compliance on
laboratories?
- How to best prepare for FDA inspections
- What are the incremental costs of compliance?
How does the audio seminar help:
Answers will be presented by Dr. Ludwig Huber in a new
interactive audio seminar. This semimar is intended to introduce
biochemists and biologists working in biopharmaceutical development
and quality control laboratories to FDA and equivalent international
requirements. It is also useful for quality managers and staff and
for everybody else involved in the registration process of
biopharmaceuticals. The seminar will also give strategies and
specific recommendations for regulated laboratories. In addition
attendees will get tool kits for effective implementation. ..
During the interactive presentation you learn about:
- Key difference between regulated and non-regulated
laboratories
- The most important regulations and guidelines related to
biopharmaceutical laboratories
- The compliance "hot-spots" the FDA investigators look for
during inspections
- Regulations as they apply to different lifecycle phases:
GLP, GCP, cGMP
- Requirements along the sample workflow, from sampling to
testing, data evaluation, reporting and data archiving
- Qualification of equipment and validation of analytical
methods
- Eight essential steps for effective implementation
- Internal audits as an ideal preparation for FDA inspections
- Incremental Costs of Compliance
And for easy and instant implementation:
download 10+ documents from special seminar website
- PowerPoint Presentation
- Script of the presentation
- 70-page primer: Compliance for Biopharmaceutical
Laboratories
- 70-page primer: Analytical Instrument Qualification and
System Validation
- 70-page primer: Validation of Analytical Methods
- SOP: Archiving and Retrieval of GMP Data and other
Documents
- SOP: Training of Laboratory Personnel
- SOP: Generation and Maintenance of SOPs for Laboratories
- SOP: Validation of Bioanalytical Methods
- Checklist: FDA Requirements for Biopharmaceutical
Laboratories
- Regulatory reference documents: Required Records for
Laboratories
- ICH Q6B: Test Procedures and Acceptance Criteria for
Biotechnological/biological Products
- Reference Paper: Analytical tools for Characterization of
Biotechnology Products and Processes (link)
- FDA warning letters and Inspectional observations related to
laboratories.
- FDA and International guidance documents and predicate rules
Who should attend?
- Biochemist and Biologists working in biopharmaceutical
laboratories
- Documentation professionals
- QA managers and personnel working for 'bio'pharmaceutical
companies
- Analysts and lab managers
- Human resources (HR) managers and staff
- Training professionals
- Consultants
Date and time
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.
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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, |