Industries: Pharma / Biotech

Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products

Course Director: Judy Carmody, Ph.D.

Course Fee: $2150.00 Regular Registration / $1950.00 Early Bird (30 Days in Advance)

  Accreditation: ***RAPS Approved Course***

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.

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.

Course Agenda

First Day

Section 1: Regulatory Requirements/Guidance on Analytical Method Validation

  • Terminology defined: scientifically sound and appropriate, qualification, validation, revalidation and verification
  • FDA, EMA, ICH and WHO requirements and guidance
  • Validation lifecycle for analytical methods
  • When during clinical development is analytical method validation required?

Section 2: Analytical Method Pre-Validation – Stage 1

  • Analytical Target Profile (ATP)
  • ICH Q8, Q9 and Q10 adherence - Pre-Validation Requirements
    • QC instrumentation qualification
    • Training
    • Critical assay reagent qualification

Section 3: Analytical Method Validation Characteristics – Stage 2

  • Specificity, accuracy, precision, linearity, range
  • LOD and LOQ
  • Robustness and stability-indicating
  • Value of system suitability controls

Exercise 1:  Quantitative Impurity ELISA (Host Cell Proteins)

  • Detecting trace amounts of contaminating protein in a protein product
  • Nature of the test method
  • Intended use for the test method
  • Review what others have done – in class activity

Section 4: Test Method Validation Protocol

  • 8 basic elements of a validation protocol
  • Pre-planning and planning steps
  • Identification and documentation of assay characteristics needing to be validated
  • Critical importance of assigning pre-defined acceptance criteria

Second Day

Section 5: Validation Exercise:  Quantitative Potency Bioassay (Cell Lysis)

  • Adequate bioassay development and optimization precedes validation
  • Impact of physics, biology, chemistry and mathematics on bioassay performance
  • Dilutional linearity
  • Regression line analysis

Section 6: Test Method Validation Report

  • 11 basic elements of the validation report
  • Relationship of the validation protocol to the validation report
  • Meeting the pre-defined acceptance criteria
  • Handling deviations/OOS’s, when (not if) they happen

Section 7: Regulatory Authority Concerns About Test Method Validations

  • Report card from the regulatory authorities on test method validation
  • Validation issues identified during the review of the submitted market dossier
  • Validation issues identified during regulatory inspections
  • Test method validation “continuous improvement” – ICH Q10

Exercise 2: Nucleic Acid Amplification (Mycoplasma PCR)

  • Inclusion specificity for rapid detection of adventitious agents
  • LOD determination of mycoplasma contamination in bioreactors
  • Universal DNA primer selection
  • System suitability control selection

Learning Objectives

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.


"This is the best course I’ve ever taken. It provided me with the knowledge I need to use immediately at work.." Ximin C., Senior Scientist, enGene
"Superior! It was exactly as advertised (unlike some I've taken with CFPA). Material was understandable although I am far from a technical expert." Robert H., Sr. Research Scientist, Janssen
"This was my first Method Validation course but I have taken courses with other vendors. The scope of this course was very well laid out end to end and the handout materials will come in handy for years to come. Clear and concise validation with great examples!" Brittany L., QC Specialist, Medicago
"Very experienced course director and provided great insights from her experience." Sharmilapriya M., Process Engineer, MTA2
"The course was very useful for me and the course director was very helpful." Wael M., Asst. Professor, King Saud Univ.
"Course was well paced and presented. The trainer was very knowledgeable and informative." Brendan H., QC Scientist, BioMarin
"Very good course - exactly what I wanted and needed. A good broad range of examples; lots of real-life examples, both good and bad. I would recommend this course and the instructor." Mark M., Sr. Res. Scientist, DPT Labs
"I loved the course. The pace was perfect, the organization of the content was incredible. The course director was knowledgeable and articulate. Most impressive is the fact that he presented the subject with both points of view – industry and regulating agency – clearly and objectively at the same time." Hoai C., Pharmacologist, FDA
"This was the best course that I have taken! I really appreciated the exercises; more courses should include these types of applications." David D., Interim Director, UNC Vector Core
"Great course! You did a really good job of making dry subject material very interesting. You really held my attention during the whole course. It was a good mix of discussion and lecturing." Sonya S., Analytical Scientist, Micromet
"Excellent presenter who made the topic both interesting and informative through interaction with the class, many excellent tips, suggestions and references were provided. Much of the mystery surrounding test method validation was explained and clarified. The course notes will prove to be an excellent reference source." Douglas R., Manager R&D, QA GMP Compliance, Sanofi Pasteur
"The Course Director was engaging and kept our attention well. Exercises were appropriate and helpful to understanding the material. This course was very helpful to me as a Quality representative that will be providing guidance and validation requirements." Christine E., Assoc. Director, Venture Quality, Janssen R&D
"This course was very useful. I walked in not knowing anything about test method validation, but walked out with good information to introduce to my company. The course director was very interesting, smart, realistic, very knowledgeable about regulations and common problems companies face. The content of the course is very useful and interesting with the examples provided." Rania, QA Engineer, Integra LifeSciences
"This course provided the road map to methods validation (through the course material) that is often hard to find elsewhere in guidance documents, forums, etc." Mike D., Senior Scientist, Johnson & Johnson
"Excellent course!! The Course Director is very knowledgeable and provided very clear educational materials with representative examples." Jian H., Sr. Research Chemist, Merck
"This course was an excellent background on method validation." Mark C., Validation MGR, OPTI Medical Systems
"The course director was good at letting good discussions run and that can be most helpful. He made us think and answer the in-class questions, which was a good idea. It will help me remember the material." John G., Research Scientist, Talecris Biotherapeutics
"This was one of the most interesting and helpful training courses I have ever taken. The course director is very interesting and engaging." Tamiru B., Alexis
"The course director had excellent presentation and communication skills. He was knowledgeable of the topics presented and he was able to answer all of the questions asked. Great Job!" Tomas T., Associate Scientist, Merck

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.

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CfPIE is committed to enhancing the ongoing professional development of regulatory affairs professionals and others through appropriate regulatory affairs learning activities and programs.  CfPIE has agreed to follow RAPS-established operational and educational criteria.  Click here for the list of courses reviewed and approved by RAPS.