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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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On-line Audio Seminar 324

Elemental Impurities According to the new ICH Q3D and USP 232/233 Guidelines

With updates on selected elements, limits, analytical procedures and schedule

Recorded, available with all reference material at any time

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ICH has officially released Draft 2 of the ICH Q3D guideline on elemental impurities. According to ICH this new guidance provides a global policy for limiting metal impurities in drug products and ingredients. ICH Q3D proposes elements and limits that are quite similar to USP <232>. In addition to USP <232> ICH also suggests risk based control strategies to reduce the impurities to below the limits. On the other hand USP through chapter <233> also suggests methodology and equipment for the analysis of impurities that are not included in ICH Q3D. So the industry has lots of questions what to do to comply with both guidelines..

Key Questions related to elemental analyses are:

  • What do FDA and other regulations say about metal analysis?
  • What exactly are the expectations of inspectors?
  • Why do we need new guidelines for elemental impurities? The principle behind USP 231 worked for more than 100 years
  • What is the approach of ICH for elemental impurities?
  • What is the rational behind the selection of the elements and limits of Q3D?
  • What is the scope of the guideline. raw material, APIs, finished drugs?
  • How can we establish impurity concentrations from Permitted Daily Exposures
  • How do the ICH elements and PDE limits compare with USP <232>?
  • What does the ICH guideline recommend about analytical methods and instruments?
  • What do USP and EP recommend for analytical procedures and equipment?
  • How to combine both guidelines: ICH and USP?
  • Do we need any additional new equipment for measurement?
  • What is the timeline for final implementation?

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, case studies, 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:

  • FDA and equivalent international requirements
  • Background of elemental impurity guidelines
  • The approaches of the ICH Q3D and USP guidelines
  • Scope of the guidances: what needs to be controlled
  • Principles of safety assessment of potential impurities
  • Elements and limits for drugs and drug substances
  • ICH Q3D classification for elemental impurities
  • Permitted daily exposure (PDE) for different routes of administration
  • Options to calculate concentration limits from PDE
  • Justification for Impurity levels higher than the PDE
  • Risk based control of elemental impurities: initial and on-going
  • Similarity and difference between ICH Q3D and USP <232>
  • Recommendations for risk based controls of elemental impurities
  • ICH and USP recommendations for analytical procedures and equipment
  • Recommendations to laboratories for planning
  • Examples and case studies
  • Most frequently asked questions

And for easy and instant implementation:
download 10+ documents from special seminar website

  • PowerPoint Presentation
  • Script
  • All questions and answers from before, during and after the seminar
  • 43-page Primer published by Agilent Technologies (link)
    Elemental Impurity Analysis In Regulated Pharmaceutical Laboratories
  • Master Planning Templates and Examples: Elemental Impurity Analysis According to  USP <233>
  •  Example SOPs:
    - Control of Elemental Impurities according to ICH Q3D
    - Validation of Analytical Methods for Elemental Impurities
    - Analytical Instrument Qualification According to USP <1058>
    - Maintenance of Equipment
    -
    Retention and Archiving of Electronic Records
  • Checklist: Elemental Impurity Analysis According to USP <233>
  • Checklist: Control of Elemental Impurities according to ICH Q3D
  • Case studies - Elemental Impurity Analysis
  • FDA Warning Letter related to metal impurity analysis
  • USP update website for elemental impurities (link)
  • ICH Guideline Q3D; Elemental Impurities (link)
  • And more...

Scope of the ICH Guidance vs. USP Chapters

Attend the seminar to learn everything about selected elements and limits, how to control the control the limits and how to analyze elements

Limitations of existing Compendial Methods

The figure below shows a comparison of accuracy data obtained with new USP procedure <233> based on ICP/MS vs. the existing <231> based on colored sulfides. Attend the Labcompliance seminar to learn more about different modern equipment as recommend by USP.  ICH draft Q3D simply refers to Pharmacopeia procedures.

 

Who should attend?

  • (Bio)pharmaceutical and API industry
  • Contract laboratories
  • Analytical methods development
  • Raw materials testing
  • Finished product testing
  • QC directors and substitutes
  • 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

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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.

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,