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.
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?
Mr Gregory Martin,
Complectors Consulting provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin 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 has over 25 years experience in the pharmaceutical industry and was 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 as Vice Chair of the General Chapters – Physical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Weights and Balances and Use of Enzymes for Dissolution Testing of Gelatin Capsules. He is also Chair-elect of the AAPS In Vitro Release and Dissolution Testing Focus Group. He serves on the Editorial Advisory Board of the Journal of Validation Technology and Journal of GXP Compliance
- 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