Full-day Virtual Seminar: Validation of Analytical Procedures for Use in the Pharmaceutical Industry

This 6-hr virtual seminar will review analytical procedures used in assessing quality, safety and efficacy of drug products. It will cover the ICH and USP guidelines for procedure validation and help you ensure robust validation of analytical procedures for drug substances and products.

Why Should You Attend:

This 6-hr training will examine the analytical tools used throughout a drug product life cycle. There is a broad range of assays and techniques used to measure the quality, safety and efficacy of a drug substance or a drug product. The training will challenge attendees to give thoughtful evaluation of their current strategies or to develop strategies from the ground up. The CFR regulations and guidance from the USP and ICH will be used as references and in support of creating a sound approach to the validation of analytical procedures for drug substances and products.

Learning Objectives:

• To grasp the importance of procedure selection
• To understand the purpose of establishing sound approaches to understanding the quality attributes of a drug substance or a drug product.
• To gain an understanding of the necessary relationship between GLP and GMP.
• To understand the pitfalls and risks of incomplete or non-robust validation.
• To strengthen understanding of the importance of upfront work.

Areas Covered in the Seminar:

• Review of procedures used in assessing quality, safety and efficacy of drug products.
• ICH and USP guidelines for procedure validation.
• ICH guidelines and Good Manufacturing Practice (GMP).
• Good Laboratory Practice (GLP).
• Phases of clinical trials and the path to commercialization.
• Key aspects involved in procedure validation.
• Complex procedures.
• Laboratory responsibility to assuring validation is robust.

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