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All documents shown here are included in the seminar for instant download

FDA industry Guidance
Residual Solvents in Drug Products Marketed in the United States

5 Warning Letters/483 related to residual solvent analysis

Residual Solvents:
FDA/ Regulatory Perspective

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.

On-line Audio Seminar 206

Residual Solvent Analysis According to USP <467>

Understanding and implementing the new USP chapter

Recorded

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On July 1, 2008, the USP released a new major revision of it's general chapter <467>: now entitled Residual Solvent Analysis. Using the risk based approach solvents have been broken down in three classes with different requirements for maximum limits. Over the last few years there were lots of discussions during the development of the chapter, and still today the industry is unsure on how to implement it. Key questions are:   

Key Questions related to residual solvent analysis are:

  • The USP has a new revision for the residual solvents: how can you best implement it?
  • Who is responsible for compliance with USP <467> - Supplier, Drug Manufacturer?
  • How far can drug manufacturers take supplier guarantees?
  • How much testing is required: limit vs. quantitative testing?
  • Should test procedures be validated?
  • How to determine the maximum limits?
  • What is the difference between ICH Q3C and USP <467>
  • What is the difference to the European Pharmacopeia?
  • Are USP general chapters legally mandatory?
  • Do we need to control drugs and APIs not described by USP monographs?
  • What exactly are FDA expectations and documentation requirements?

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 strategies and give practical recommendations. After the seminar, an extensive list of reference material like primers, SOPs, templates and reference articles will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • History of requirements for Residual Solvent analysis
  • FDA, ICH and European General Requirements for Residual Solvents
  • Detailed USP <467>requirements: changes to previous version
  • Classification of solvents: Class 1, 2 and 3
  • Determination of residual solvent limits for three classes
  • Analytical procedures A, B and C - Methodology and Validation requirements
  • Quantitative tests vs. limit tests: when to apply which with decision tree
  • Using alternative methods: when and how
  • FDA expectations: Going through the Industry and Office of Generics Guidance
  • Using test results and other information provided by suppliers
  • Recommendations for implementation

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

  • SOP: Auditing of Suppliers
  • Master Plan: Template and Examples -
    Residual Solvents Analysis According to USP <467>
  • Checklist: Implementing USP <467> . Residual Solvent Analysis
  • Publications (Links)
    - Tips to Meeting the Criteria of the Upcoming Revised USP Monograph <467>: Residual Solvents
    - Determination of extractables, leachables, residual solvents and unknowns by mass spectrometry
    - Organic volatile impurities; Good overview article on residual solvent analysis
    - Revised USP 467 Residual Solvent Method
    - USP Chapter 467 Revision Bulletin
    - USP: Delayed Implementation for General Chapter <467> Residual Solvents
    - Residual Solvents as per USP <467>
  • USP: Answering frequently asked questions
  • FDA Guidance for Industry (draft)
    Residual Solvents in Drug Products Marketed in the United States
  • FDA Guidance (final):
    USP Chapter <467> Residual Solvents for Generic Drugs
  • FDA Presentation: Residual Solvents - FDA/ Regulatory Perspective
  • Five Warning letters and Inspectional observations related to residual solvents

Who should attend?

  • Training departments
  • QA managers and personnel
  • Analysts and lab managers
  • Validation specialists
  • Regulatory affairs
  • Human resources (HR) managers and staff
  • Documentation department
  • Consultants

How to order

Pick one of the options in the table that fits your needs. 

Recorded seminar - Web download 'Site' offer

  • 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.