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

Instructor: Gregory Martin
Product ID: 705733
  • Duration: 90 Min
This webinar will discuss the new elemental impurities test requirements as per the new ICH Q3D and USP 232/233 Guidelines, the testing required to comply with it and how to do proper risk assessment and analytical measurements, which drug products are within the scope, the documentation related to control of elemental impurity, which methods required to be validated.
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Why Should You Attend:

Manufacturers of new drug products are required to comply with the new elemental impurities standards either thorough risk assessments or through testing as new regulatory submissions are made, whereas manufacturers of existing products while making decisions regarding the extent of risk assessment and testing required need 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 in the Webinar:

  • Elemental Impurities: The case for change
  • Regulatory status: FDA, ICH Q3D, USP 232/233
  • Scope of the new guidance on Elemental Impurities - 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
  • Implementation of the Guidelines
  • Which procedures can be used to demonstrate compliance
  • Analytical Procedures and how methods should be validated
  • 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
Instructor Profile:
Gregory Martin

Gregory Martin
Founder and President, Complectors Consulting LLC

Gregory Martin is President of Complectors Consulting (www.complectors.com), which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin has over 25 years’ experience in the pharmaceutical industry, including Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company to solving challenging problems. He provides consulting services to over 50 companies, including human and veterinary pharmaceutical companies, manufacturers of OTC and nutritional supplement products, and contract organizations.

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 also serves on the Steering Committee of the AAPS IN Vitro Release and Dissolution Testing Focus Group.

He has particular interest in QbD/Lean approaches to dissolution testing, method lifecycle (development/validation/transfer), impurity testing 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 has presented at several scientific meetings, and authored of several papers in the areas of dissolution and analytical method validation.

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Analytical Method Validation
Quality Control Laboratory Compliance

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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