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?
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?
Speakers
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.
