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.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
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.
Elemental Impurities: The case for change
Overview of Guidance Documents: FDA, ICH Q3D, USP
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 Managers, Laboratory Managers, Directors, Supervisors, Laboratory Technicians / Operators, Analytical Chemists, Laboratory Managers, Regulatory Compliance Managers, Quality Control and assurance managers, Chemical Manufacturing and Control managers