OVERVIEW

New, dramatically different requirements for elemental impurities will soon be introduced 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 Impurites 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
FDA has issued a Draft Guidance on Elemental Impurities in Drug Products, which addresses ICH Q3D and USP General Chapters 232 and 233 on this topic.

Who will Benefit
Pharmaceutical R&D and QC chemists and their managers; Regulatory Affairs personnel, including those responsible for filing NDAs and ANDAs or other drug products and those responsible for Annual Reports and updating analytical methods and specifications. Individuals at Contract Manufacturing and Contract Laboratory facilities should also attend.