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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
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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

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c 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  • FDA has adapted ICH M7 as FDA draft: Does this mean the existing FDA guide is obsolete?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.-
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Recorded seminar - CD

  • Get the CD in your mail
  • Order includes all reference material.

US$ 399.-
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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:

  1. Study the printed slide material
  2. Watch the slides on a computer
  3. Watch the slides on a video screen in a seminar room
  4. 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.