Course "Lifecycle Approach to Analytical Methods for Drug Products: Incorporating QbD Concepts into Method Development, Validation, Verification and Transfer" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Course Description:

This highly interactive course is designed to provide participants with a lifecycle approach to developing and validating analytical methods, including elements aligned with QbD concepts. Some of the key aspects of the seminar include:

  • Learning how to apply QbD concepts to analytical methods
  • Discussing the types of methods required for different drug products
  • Understanding the types of impurities which must be addressed for drug products
  • Discovering how a lifecycle approach can link method development, validation, verification and transfer
  • Learning how ATP (Analytical Target Profile) can drive the lifecycle approach
  • Determining the importance of linking method uncertainty to specifications
  • Using a method feedback loop to facilitate method improvement

This approach will be linked with current compendial requirements. There will be opportunities for questions and interaction throughout the course as well.

Learning Objectives:

  • Understand the lifecycle approach to method development and validation
  • Understand the different methods required for various drug products and the types of impurities which must be addressed
  • Identify an ATP for methods being developed
  • Use an IQ/OQ/PQ approach to method qualification
  • Develop appropriate protocols for method transfer
  • Comply with compendial requirements with greater success and fewer resources

Who Will Benefit:

This seminar on QbD concepts in method development will prove highly beneficial to professionals working in pharmaceutical (human and veterinary), generic or OTC companies or contract research organizations who are responsible for development, validation, verification or transfer of analytical methods.

  • Chemists (Research, Quality Control, CRO)
  • Regulatory Affairs/CMC Personnel
  • Laboratory Managers and Staff
  • Analysts
  • QA/QC Managers and Personnel

Course Outline:

Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

  • Introduction: using a lifecycle approach for analytical procedures
  • Types of methods required for various drug products
  • Impurities which must be addressed for drug products
    • Impurities
    • Degradants
    • Elemental impurities
    • Residual solvents
  • Method design: introducing the concept of ATP
    • Practical exercise: developing an ATP

  • Method development using the ATP as a tool
    • Assay or uniformity
    • Dissolution
    • Stability indicating methods
    • Practical exercise: approach to developing a stability indicating method
  • Method validation: applying the concepts of ICH Q2 and USP <1225>
    • Rationale for demonstrating the validity of an analytical method
    • Lifecycle approach to method validation
    • Design of validation experiments
      • Establishing acceptance criteria
    • Practical exercise: designing a validation protocol
  • Method modifications: change control and method revalidation strategies
  • Verification of compendial procedures
  • Method transfer
  • Troubleshooting analytical methods
  • Questions and discussion

Meet Your Instructor

Gregory P. Martin
President of Complectors Consulting LLC

Gregory P. Martin is president of Complectors Consulting which provides consulting and training in the area of pharmaceutical analytical chemistry. Mr. Martin has over 25 years’ experience in the pharmaceutical industry and was director of pharmaceutical analytical chemistry (R&D) for a major pharma company for a number of years. In addition, he has volunteered for the USP (U.S. Pharmacopeial Convention) for over 10 years, and currently serves as Vice Chair of the General Chapters – Physical Analysis Expert Committee. He also serves on expert panels on validation and verification, weights and balances, residual solvents and use of enzymes for dissolution testing of gelatin capsules.

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. He is also past chair of the AAPS in vitro release and dissolution testing focus group. Mr. Martin is author of several papers in the areas of dissolution and analytical method validation.

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