New Elemental Impurities Tests for Pharmaceutical Products According to the New ICH Q3D and USP 232/233 Guidelines

Duration: 90 Minutes
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The deadline for implementation of the new elemental impurities guidelines for drug products and ingredients is fast approaching. Implementation is scheduled for January 2018, by which time manufacturers of pharmaceutical drug products must comply with USP <232>/<233> and ICH Q3D.
Elemental Impurity
Instructor: Gregory Martin
Product ID: 505938
A new, dramatically different requirement for elemental impurities is applied for most pharmaceutical products. These requirements cover more metals and require lower limits than the antiquated Heavy Metals test. Additionally, the analytical technique, ICP-MS, is much more challenging. By attending this course you will learn about the new requirements and also about using risk assessment to minimize unnecessary testing and meet FDA expectations.

Objectives of the Presentation
  • How the new FDA Guidance on Elemental Impurities is related to ICH Q3D and USP Chapters 232 and 233
  • What drug products are within the scope of the guidance
  • Which classes of drug products need to comply with ICH Q3D and which with USP 232/233
  • How risk assessment influences what testing is required
  • What documentation related to control of elemental impurities is expected by FDA
  • Which procedures can be used to demonstrate compliance
  • How methods should be validated
Why Should you Attend
The subject is of importance to the manufacturers of new drug products as they will be required to comply with the new elemental impurities standards either through thorough risk assessments or through testing as new regulatory submissions are made, and to manufacturers of existing products as they make decisions regarding the extent of risk assessment and testing required to demonstrate compliance with the new standards. If the manufacturer's compliance strategy involves testing, there are many things to consider regarding the selection of the correct analytical technique (e.g., atomic absorption, ICP emission spectroscopy, ICP mass spectrometry).

The objective of this live training webinar is to provide an understanding of the new standards and guideline, what testing is required in order to comply with the spirit of the documents, how to perform a proper risk assessment, and how to perform suitable analytical measurements.

Areas Covered
  • Elemental Impurities: The case for change
  • Overview of Guidance Documents: FDA, ICH Q3D, USP 232/233
  • Scope of the guidance's
  • Risk Assessment
  • FDA Recommendations
  • Controls and Documentation
  • Analytical Procedures and Validation
  • What you should be doing now
Who will Benefit
  • Researchers/ R&D Mangagers
  • Laboratory Managers/ Directors / Supervisors
  • Laboratory Technicians / Operators
  • Analytical Chemists
  • Laboratory Managers
  • Regulatory Compliance Managers
  • Quality Control and assurance managers
  • Chemical Manufacturing and Control managers
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
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  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Greg Martin is the President of Complectors Consulting, which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin has over 25 years experience in the pharmaceutical industry and was the Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years. In addition, he has volunteered for the USP for over 10 years, and currently serves on the General Chapters - Chemical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules.

He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources. Mr. Martin is the author of several papers in the areas of dissolution and analytical method validation, and was the past chair of the AAPS In Vitro Release and Dissolution Testing Focus Group.
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