COURSE ID 3141

Revalidation and Compliance in Life Cycle Management for Analytical Methods Validation

AVAILABLE LIVE ONLINE
Date(s) and Time:
January 23, 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 9, 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 essential principles and practices related to method validation in regulated environments. The course covers key topics including revalidation, method revisions, and compliance issues in method validation. You will explore FDA-mandated updates, changes
in drug substance, product, method/site, and technology that require revalidation. Additionally, the course addresses common compliance challenges such as inadequate validation, robustness issues, errors in validation plans, and improper instructions (SOPs), as well as the importance of maintaining equipment and ensuring proper training to minimize non-compliance.

In addition, we will delve into life cycle management of analytical methods, examining real-world examples of method development and validation. Topics include a comparison of UHPLC vs. HPLC methods, ligand binding assays, and the application of advanced techniques such as LC-MS-MS.

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 3: Process, Application, and Data Analysis for Analytical Method Validation

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

  • Define key factors that necessitate revalidation, including drug substance, product, method/site, and technology changes.
  • Describe FDA guidelines and updates related to method revisions.
  • Explain the significance of method compliance issues.
  • Apply strategies to mitigate common compliance issues.
  • Compare and contrast different analytical techniques such as UHPLC vs. HPLC, ligand binding assays and LC-MS-MS in method development and validation.
  • Develop a life cycle management strategy for maintaining validity.

COURSE OUTLINE

Revalidation and Method Revisions

  • Drug Substance Changes
  • Drug Product Changes
  • Method/Site Changes
  • Technology Changes
  • FDA Mandated Update

Validated Method Compliance Issues

  • Inadequate Validation
  • Method robustness issues
  • Errors in validation plan/report
  • Unclear or deficient instructions such as SOP or Standard Test Method
  • Equipment logbooks, routine maintenance, qualification/calibration
  • Inadequate Training leading to non-compliance issues
  • Lengthy test procedures leading to human error

Life Cycle Management of Analytical Methods
Examples of Approaches to Method Development and Validation

  • UHPLC vs. HPLC Methods
  • Ligand Binding Assays
  • Application of LC-MS-MS
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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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