AAPS Career College
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Development, Validation, Verification and Transfer of Analytical Methods

A One Half Day On-site Short Course

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Distinguished Faculty

Gregory P. Martin, President
Complectors Consulting LLC
Pottstown, PA

Greg Martin is President of Complectors Consulting (www.complectors.com) 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.  He serves on the Editorial Advisory Board of the Journal of Validation Technology and Journal of GXP Compliance.  He can be contacted at greg.martin@complectors.com.


Registration Fee Includes

Presentation Materials, Luncheon, Refreshment and Free Parking

Note: Please indicate any special Dietary requirements when registering for the course

Dates Available

June 20-21, 2012

Time

8:30 a.m - 5:00 p.m.

Cost

CAD $895.00 + HST

Location

AAPS Training Center
200 Consumers Road, Suite 200, Toronto, Ontario, M2J 4R4
Tel: 416-502-2277

Goals and Objectives

This interactive 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 stage in more detail including concepts and practical suggestions.  We will use concepts from personal experience, from ICH and USP documents as well as some additional concepts from a recent paper on a QbD approach to method lifecycle.  The course will address specific requirements for chromatographic methods intended for monitoring impurities and degradates, chromatographic methods where the focus is on measuring the active ingredient and non-chromatographic methods.  There will be ample opportunity for participant questions and discussion throughout the course.

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

  1. Identify the various stages in the lifecycle of an analytical method and the expectations at each of those stages.
  2. Apply the concept of the Analytical Target Profile for improving the design and evaluation of analytical methods.
  3. Approach method development using the Analytical Target Profile as a tool to increase the effectiveness of the exercise.
  4. Discuss the appropriate guidance documents related to method validation, verification and transfer.
  5. Identify the required elements for method validation, verification or transfer experiments.
  6. Troubleshoot methods which are not performing well.

Contents

  1. Assessment of Student Needs and Interests
  2. Introduction: Using a Lifecycle Approach for Analytical Procedures
  3. Method Design: Introducing the concept of the Analytical Target Profile
    1. PRACTICAL EXERCISE: Developing an ATP
  4. 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
    1. Assay or Uniformity
    2. Dissolution
    3. Stability indicating methods
    4. PRACTICAL EXERCISE: Approach to developing a stability indicating method
  5. Method Validation: Applying the concepts of ICH Q2 and USP <1225>
    1. Rationale for demonstrating the validity of an analytical method
    2. Life cycle approach to method validation
      1. Early development
      2. Later development
      3. Transfer to other laboratories
      4. Verification of methods from outside sources, including Compendia
    3. Design of validation experiments
      1. Chromatographic methods designed to be selective for impurities and degradates
      2. Chromatographic methods designed to measure the primary component
      3. Non-chromatographic methods
    4. PRACTICAL EXERCISE: Designing a validation protocol
  6. Method Modifications: Understanding the rationale for change and addressing effective change control and method revalidation strategies
  7. 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.
    1. PRACTICAL EXERCISE: Designing a verification protocol
  8. Method Transfer: Identifying acceptable approaches to transfer of methods between laboratories, data elements which must be addressed and appropriate documentation.
    1. PRACTICAL EXERCISE: Designing a method transfer protocol
  9. Troubleshooting analytical methods
    1. Discussion of examples of methods where validation criteria were not met
  10. Questions and discussion

Who Should Attend

Chemists, supervisors, managers or directors from pharmaceutical companies, generic companies or contract research organizations who are responsible for development, validation, verification or transfer of analytical methods, and regulatory affairs/CMC personnel responsible for filings involving analytical methods.

Certificate of Attendance and Course Material