This two-day course is designed for those who perform, supervise, manage, audit, or oversee the validation of test methods for the quality control of biologic and biopharmaceutical products. This includes, but is not limited to, professionals in Analytical Development, Quality Control, Quality Assurance, and Validation groups. The course will also benefit those in other departments who find test method validation among their responsibilities. 

While the course focuses on test method examples for biologics and biopharmaceuticals, the principles and practices of test method validation taught in this course are universal for all therapeutic pharmaceutical products.

Learning Objectives

Upon completion of this course you will have a clear understanding of international regulatory authority regulations and expectations and will have gained the background knowledge necessary to effectively plan and execute QC test method validation programs. You will have gained expertise in writing test method validation protocols and reports and in setting acceptance limits for validation. You will have acquired insight into how to avoid common validation pitfalls and be able to quickly discriminate compliant from non-compliant test method validation activities.

Course Description

Complex processes yielding complex products such as biologics and biopharmaceuticals demand numerous, non-compendial, and sometimes complex, QC test methods to confirm manufacturing consistency and product quality.  This course provides a comprehensive overview of the international regulatory authority requirements and expectations for test method validation of these assays.  This course will prepare attendees with the knowledge and tools to plan and execute test method validation packages for the NDA, BLA and MAA market application dossiers, covering in-process, release and stability assays commonly used by QC in biologic and biopharmaceutical companies. 

The course will cover validation of QC analytical test methods (e.g., electrophoretic, HPLC, peptide mapping, etc.), cell-based potency bioassays, immunochemical binding impurity assays and adventitious agent assays.