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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Understanding the New USP Chapters 232/233 for Metal Impurities

With SOPs and Case Studies for Easy Implementation

Recorded, available with all reference material at any time

USP plans to significantly change the way we do metal analysis in drugs and dietary ingredients. In January 2010 USP had proposed three new chapters with new requirements for limits and recommendations for analysis. In May 2011 USP issued updates to the chapters and by 2013 the current chapter <231> will be obsolete. 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 companies 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 first drafts and the updated chapters?
• 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 steps are included in analytical instrument qualification?
• What are the suggested and required detection and quantification limits?
• What 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 backgound 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 chapters
• Differences between the first drafts and updates from May 2011
• Elemental limits for different classes of impurities
• Comparison with EU requirements
• Qualification of instrumentation
• Alternative options for method validation
• Validation of quantitative procedures using reference material
• USP timeline for the chapters
• 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>
• 5 Example SOPs:
  - Validation of Analytical Methods for Elemental Impurities
  - Analytical Instrument Qualification According to USP <1058>
  - Maintenance of Equipment
  - Development of User Requirement Specifications for Analytical Equipment
  - Qualification of Equipment
• Checklist: Elemental Impurity Analysis According to USP <233>
• 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...

Who should attend?

• (Bio)pharmaceutical and API industry
• Food 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 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.-
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.-

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.