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Analytical Method Lifecycle: From Design and Development through Validation and Transfer

Webinars - Analytical Method Lifecycle: From Design and Development through Validation and Transfer
Webinars

By : Compliance Online

Date : 2011

Location : United States US / Palo Alto

Video 01h 50m
Description :

This webinar/training will give a lifecycle approach to assuring analytical methods are suitable for their intended use. It will detail the stages of an analytical method and provide practical suggestions.

Keywords :

Analytical Method Lifecycle, ICH Q2, USP <1225>

 

This course is designed to offer a lifecycle approach to assuring analytical methods are suitable for their intended use. After an introduction to the stages of an analytical method, we will discuss each in more detail including concepts and practical suggestions. We will use concepts from ICH and USP documents as well as some additional concepts from a recent paper on a QbD approach to method lifecycle.

At the conclusion of the presentation, there will be ample opportunity for participant questions and discussion.

 

Who Will Benefit:

Chemists or managers responsible for development, validation, verification or transfer of analytical methods, and regulatory affairs/CMC personnel responsible for filings involving analytical methods.

  • QC personnel
  • QC Supervisors and Management
  • QA personnel
  • QA Management
  • Regulatory affairs personnel
  • R&D Lab personnel
  • R&D Lab Supervisors

 

Learning Objectives:

Upon completion of the course the learner should be able to:

  • Identify the various stages in the lifecycle of an analytical method and the expectations at each of those stages.
  • Apply the concept of the Analytical Target Profile for improving the design and evaluation of analytical methods.
  • Discuss the appropriate guidance documents related to method validation, verification and transfer.
  • Identify the required elements for method validation, verification or transfer experiments.
  • Troubleshoot methods which are not performing well.

 

Areas Covered in the Seminar:

  • Introduction to using a Lifecycle Approach for Analytical Procedures.
  • Method Design:  Introducing the concept of the Analytical Target Profile.
  • Method Development:  Based on the ATP and adapting existing methodology, consider development as a process which anticipates validation needs and uses a QbD approach to exploring limits for enhancing method understanding.
  • Method Validation:  Applying the concepts of ICH Q2 and USP <1225> to demonstrate validation, including situations with multiple potencies.
  • Method Modifications:  Understanding the rationale for change and addressing effective change control and method revalidation strategies.
  • Method Verification:  Understanding the requirements when a compendial or similar method is brought into the laboratory, and the data elements which must be addressed to verify the method is suitable for its intended use.
  • Method Transfer:  Identifying acceptable approaches to transfer of methods between laboratories, data elements which  must be addressed and appropriate documentation.
  • Method Troubleshooting:  What to do when things do not go according to plan.

 

Agenda:

 

  • Introduction:  Using a Lifecycle Approach for Analytical Procedures
  • Method Design:  Introducing the concept of the Analytical Target Profil
  • Method Development:  Based on the ATP and adapting existing methodology, consider development as a process which anticipates validation needs and uses a QbD approach to exploring limits for enhancing method understanding 
  • Method Validation:  Applying the concepts of ICH Q2 and USP <1225> to demonstrate validation, including situations with multiple potencies
  • Method Modifications:  Understanding the rationale for  change and addressing effective change control and method revalidation strategies
  • Method Verification:  Understanding the requirements when a compendial or similar method is brought into the laboratory, and the data elements which must be addressed to verify the method is suitable for its intended use.
  • Method Transfer:  Identifying acceptable approaches to transfer of methods between laboratories, data elements which  must be addressed and appropriate documentation
  • Method Troubleshooting:  What to do when things do not go according to plan.
  • Summary and Conclusions
  • Questions and Discussion

 

Instructor

 

Greg Martin, is President of Complectors Consulting which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources. Mr. Martin has over 25 years experience in the pharmaceutical industry and was Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years. In addition, he has volunteered for the USP for over 10 years, and currently serves as Vice Chair of the General Chapters – Physical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Weights and Balances and Use of Enzymes for Dissolution Testing of Gelatin Capsules. He is also Chair-elect of the AAPS In Vitro Release and Dissolution Testing Focus Group.

 

QbD Approach to Analytical Method Lifecycle: Design, Development, Validation, Transfer

Product Type : On Demand Webinar

Author : Gregory Martin

Video 01h 50m

Languages : English

Organizer : Compliance Online

ComplianceOnline is a Regulatory Affairs Professionals Society(RAPS) RA Professional Development Portal provider. ComplianceOnline is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs ComplianceOnline has agreed to follow RAPS-established operational and educational criteria