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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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Implementing the New USP Chapters 232/233 for Elemental Impurities

Learn how to comply with FDA, USP and ICH Requirements

Recorded, available with all reference material at any time

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USP has approved final chapters to significantly change the way we do metal analysis in drugs, drug substances and raw material. The final chapters for setting specifications (<232>) and test methodology (<233>) have been approved by the USP committees. They have been published in the June revision of the USP monograph and will be effective by December 1, 2012.  ICH also plans to release a preliminary version of Q3D: ICH's guidance on elemental impurities with similar requirements. The new chapters will impact about 1000 monographs. It is well known that FDA inspectors require USP standards or equivalent procedures to follow. Therefore pharmaceutical and API manufacturers are advised to prepare themselves before the chapters will become effective.  There is lots of interest in learning about the new chapters but there are also many questions.

Key Questions related to metal analyses are:

  • What do FDA and other regulations say about metal analysis?
  • What are the differences between the draft and  final chapters?
  • What is the difference between USP chapters and the ICH Q3D guidance?
  • What exactly are the expectations of inspectors?
  • What is the rational behind the chapters?
  • What is the scope of the chapters. raw material, APIs, finished drugs?
  • How do the USP requirements compare with European requirements?
  • What are the suggested and required detection and quantification limits?
  • How to verify USP limits in our laboratory?
  • Will the general chapters overwrite methodology and limits in the individual monographs?
  • Do we need any additional new equipment?
  • Does USP allow alternative procedures?
  • What is the timeline for 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 analysis
  • Issues with USP <231>
  • The approach for the new USP chapters
  • Differences between draft and final chapters
  • Elements and limits for drugs and drug substances
  • Similarity and difference to ISO Q3D guidance
  • Comparison with EU requirements
  • Options for establishing impurity levels
  • Verification and use of recommended compendial procedurs
  • Validation and use of alternative procedures
  • Qualification of equipment
  • Validation and Part 11 compliance of computer systems
  • USP timeline for the chapters and monographs
  • 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
  • Master Planning Templates and Examples: Elemental Impurity Analysis According to  USP <233>
  •  Example SOPs:
    - Elemental Impurity Analysis According to USP <232/233>
    - 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: 21 CFR Part 11 Compliance
  • Case studies - Elemental Impurity Analysis
  • FDA Warning Letter related to metal impurity analysis
  • USP update website for elemental impurities (link)
  • USP FAQ for elemental impurities (link)
  • ICH: Final Concept Paper: Q3D: Impurities: Guideline for Metal Impurities (link)
  • ICH Final Business Plan Q3D: Impurities: Guideline for Metal Impurities (link)
  • And more...

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

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,