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.
This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.
Who Should Attend
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.
Upon completion of this course, attendees 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. Participants will have gained expertise in writing test method validation protocols and reports and in setting acceptance limits for validation. Additionally, attendees 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.
Frequently Asked Questions
How much of the course deals with method validation for chemical drugs versus biologics?
The course covers all aspects of analytical method validation with common principles applicable to chemical drug and biologic testing. Case examples that are worked on in class are based on biologic product testing. Being able to manage analytical method validation for biologic product testing is much more demanding than analytical method validation for chemical drugs.
Does the course cover FDA and international concerns?
The course covers all aspects of analytical method validation including requirements and guidance from the FDA, European Medicine Agency (EMA), World Health Organization (WHO) and International Conference on Harmonisation (ICH).
I am new to validation. Will I understand what is being presented?
The course systematically covers all aspects of analytical method validation, and leads the attendees from the basics of method validation to the application of validation principles to difficult assays such as bioassays and process-related impurity ELISAs.
How is this course different from the course on Development and Validation of Bioanalytical Assays for Biologics: Quantitation (PK) and Immunogenicity Assays™?
This course is focused on analytical method validation of chemical drug and biologic product release and stability testing assays used in a current good manufacturing practice (cGMP) environment. On the other hand, the Bioanalytical Assay Validation course focuses on method validation for assays used in testing animal and human serum and tissue samples used in a good laboratory practice (GLP) or good clinical practice (GCP) environment.