COURSE ID 3139

Development, Validation, and Application for Analytical Methods

AVAILABLE LIVE ONLINE
Date(s) and Time:
January 16, 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 January 2, 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 offers a streamlined overview of analytical method validation, focusing on key regulatory requirements set by ICH, USP, and FDA. Participants will gain practical knowledge of essential validation elements, including accuracy, precision, specificity, linearity, range, robustness, LOD/LOQ, and system suitability.

The course covers method development processes, from test selection and experimental design to the distinction between development and validation. Emphasis will be placed on writing up methods and creating standard operating procedures (SOPs).

Further topics include the validation process and application, such as product specifications, validation protocols, instrument qualification, and analyst training. The course concludes with statistical analysis of validation data, common acceptance criteria, and recommended approaches for setting criteria.

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 3: Process, Application, and Data Analysis for Analytical Methods Validation
Part 4: Revalidation and Compliance in Life Cycle Management for Analytical Methods Validation

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

  • Define key terms of ICH/USP/FDA validation requirements.
  • Identify appropriate types of methods and development parameters.
  • Differentiate between method development and validation in real-world scenarios.
  • Develop a complete method write-up and SOP.
  • Assess validation samples, standards, and instrument qualifications.
  • Compare commonly used acceptance criteria.

COURSE OUTLINE

ICH/USP/FDA Validation Requirements

  • Accuracy
  • Precision
  • Specificity
  • Linearity
  • Range
  • Robustness
  • LOD/LOQ
  • System Suitability

Method Development

  • Types of methods
  • Application
  • Method development parameters
  • Test Selection
  • Experimental Design
  • Development vs. Validation
  • Method Write Up and SOP

Method Validation Process and Application

  • Product Specification
  • Validation Protocols, Reports, and SOPs
  • Validation Samples and Standards
  • Instrument Qualification
  • Experimental Design
  • Qualified/Training Analysts

Methods Validation Statistics and Acceptance Criteria

  • Application of Statistics to Validation Data
  • Commonly Used Acceptance Criteria
  • Critical Concepts Regarding Validation Data and Criteria
  • Recommended Approach for Setting Criteria
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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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