COURSE ID 3140

Process, Application, and Data Analysis for Analytical Method Validation

With a Focus on United States Pharmacopoeia (USP) Requirements

AVAILABLE LIVE ONLINE
Date(s) and Time:
March 25, 2025
12:30 pm EST - 5:00 pm EST
Duration: 4 Hours

Can't attend the live course?
Select the on-demand option during registration, and we will automatically send you the recording when it is ready.

Course Instructor

Ahmad Farhad

Early-Bird Offer

Limited Availability until March 18, 2025

$ 525
Price
$ 585
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

This accredited course provides a comprehensive overview of key practices and regulatory requirements for method validation in pharmaceutical development. Focusing on data documentation, reporting, and compliance with FDA and USP guidelines, this session explores the essentials of experimental documentation, IND/NDA reporting, method verification (USP <1226>), and method transfer (USP <1224>). You will engage in workshops to develop validation plans and acceptance criteria. The course also covers FDA guidance on IND phase methods validation, highlighting timelines, real-world examples, and addressing common validation challenges.

Consider attending this course as part of the four-part series or as a stand-alone option for your personal career advancement and training. To deepen your understanding of analytical methods validation, the instructor recommends completing the entire series.

Part 1: Regulatory Guidance and Requirements for Analytical Methods Validation
Part 2: Development, Validation and Application for Analytical Methods
Part 4: Revalidation and Compliance in Life Cycle Management for Analytical Methods Validation

Upon completion of this course, you will be able to:

  • Define the key elements of Experimental Documentation and IND/NDA Reports in the context of method validation.
  • Explain the USP <1226> guidelines for method verification, including the procedure and interpretation of results.
  • Discuss the differences among the four options for method transfer under USP <1224>.
  • Apply FDA guidance to develop experimental plans for IND phase methods validation.
  • Assess method validation experimental plans and acceptance criteria through a workshop setting, evaluating the feasibility and accuracy of various approaches.

COURSE OUTLINE

Method Validation Data and Reports

  • Experimental Documentation
  • Elements of a Good Report
  • IND/NDA Reports

Method Verification

  • USP <1226>
  • Verification procedure
  • Interpretation and Recording of Results
  • Other Considerations

Method Transfer

  • Four Options from USP <1224>
  • Method and Lab Readiness
  • Training, Testing and Data Evaluation

Methods Validation Workshop

  • Participants will develop and discuss method validation experimental plans and acceptance criteria

IND Phase Methods Validation

  • IND timeline
  • FDA Guidance on IND Phase Validations
  • Examples of Development/Validation Studies
  • Questions and Answers Relating to Participants’ Own
  • Validation Problems
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This course is tailored for professionals entrusted with ensuring the quality and reliability of pharmaceutical/biopharmaceutical products, medical devices, diagnostics, cosmetics, and food products.

Individuals working in Quality Control, Quality Assurance, Technical Operations, and Research and Development (R&D) departments stand to gain significant benefits.

Additionally, personnel involved in Regulatory Affairs and Regulatory Agencies responsible for reviewing quality data may also find this course valuable.

Course Instructor

Ahmad Farhad Cobblestone Training Instructor

Ahmad Farhad

Managing Director at Atlas BioPharma Consulting LLC

Ahmad Farhad’s Courses

Accreditation

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