Training Course Syllabus:

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 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 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

Seminar Summary:

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 (see full course description)

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