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
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Online Audio Seminar 313
FDA/EMA Compliance of Genotoxic Impurities
Understanding and Implementing the new ICH
M7 and other Guidelines
Recorded, available with all reference material
at any time
.
Genotoxic impurities (GI)
have proven to be harmful even at low concentrations. for example,
they have the potential to cause cancer. Therefore
healthcare agencies
require specific processes
to eliminate or reduce such impurities
in drug substances and products to below specified
limits. Guidelines are available from EMA, FDA, ICH and also from industry task
forces. Unfortunately the guidances are not really specific, they leave a lot of
room for interpretation and are somewhat inconsistent. In addition,
quantitative analysis of genotoxins at the required low concentrations is not
easy So dealing with genotoxins during API and drug development and
manufacturing control is challenging, but FDA and equivalent international
organization are starting to enforce the regulations. So the industry has
many
questions.
Key Questions related to metal analyses are:
- Why are current ICH impurity guidelines not suitable for
genotoxic impurities
- Difference between Genotoxicity, Mutagenicity,
Carcinogenicity
- What are the sources for genotoxins in APIs and drug
products
- There are guidelines from FDA, EMA and industry: what is the
difference?
- ICH has just released a new guidance M7: will this become
the future standard?
- FDA has adapted ICH M7 as FDA draft: Does this mean the
existing FDA guide is obsolete?
- Do the guidelines apply for existing processes or for new
drugs only?
- Are more than one impurities additive or treated as single
impurity?
- What to do if the there are structural alerts but mutagenic
tests are negative?
- How to deal with genotoxic impurities during clinical
trials?
- What are the limits for short term use?
- Do we have to test the drugs for toxicity the APIs have no
structural alerts?
- What does "As low as reasonably practical" really mean?
- Are there reliable analytical techniques and methods for ppm
trace levels of GIs
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 background information and overview and will give practical
recommendations. After the seminar, an extensive list of reference
material like SOPs, checklists, templates and examples will help
immediate and cost effective planning for 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:
- ICH Guidelines for Impurities and their limitations for GIs
- Genotoxicity vs. mutagenicity and carcinogenicity
- Characteristics of Genotoxic impurities
- Sources of genotoxins in APIs and drug products
- Current official guidelines for GIs
- EMA position paper and final guidance: Two Category
Classifications
- Key points of the existing FDA draft guidance:
- ICH M7 Step 2 guidance: the future global standard?
- Industry and new ICH GI Classification and Controls
- The concept of Threshold of Toxicological Concern (TTC)
- Risk based approach to deviate from the official TTC
- Staged TCC for "Less Than Lifetime Use", e.g., for clinical
trials
- Recommendations to implement regulatory genotoxic impurity
guidelines
- Decision tree for Assessment of Potential Genotoxic
Impurities
- Anticipated FDA inspection and enforcement practices
- Compliance Overview for Pharmaceutical Laboratories
- Testing mutagenicity & genotoxicity
- Analytical challenges and solutions for quantitative
genotoxic trace analysis
And for easy and instant implementation:
download 10+ documents from special seminar website
- PowerPoint Presentation
- Script of the presentation
- All questions and answers from before,
during and after the seminar
- Example SOPs:
- Handling deviations from
official Threshold of Toxicological Concern (TTC)
- Assessment process for
potential genotoxic impurities
- Retention and Archiving of Electronic Records
- Qualification of analytical instruments according to USP
<1058>
- Validation of analytical methods (required by FDA/EMA/ICH)
- Validation of Commercial Off-the-Shelf (COTS) Computer Systems
- 30-page primer: Genotoxic Impurities in Pharmaceutical
Products
- Checklist: Assessment of Potential
Genotoxic Impurities
- Example: Decision tree for assessment of Potential Genotoxic
Impurities
- ICH Step 2 Guide
- New FDA draft guide (adapted from IC M7)
- And more...
Assessment of Potential Genotoxic Impurities
The figure below shows steps for assessing potential genotoxic
impurities as adapted from EMA, ICH and FDA guidelines. The seminar
will give detailed information on each step. In addition an SOP will
be available foe easy implementation.

Who should attend?
- (Bio)pharmaceutical and API industry
- Contract laboratories
- Analytical methods development
- Raw materials testing
- Finished product testing
- QA managers and personnel
- Laboratory managers and staff
- Analysts
- Training departments
- Documentation department
- Consultants
- Suppliers of test equipment
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 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 GAMPĀ® 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 explained 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, |
For more information on Dr. Ludwig Huber working with the FDA,
click here.