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

This training on using the QbD approach to analytical method lifecycle is designed to provide participants with a lifecycle approach to developing and validating analytical methods and comply with compendial requirements. The webinar presenter will use case studies to illustrate each stage in the process.

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Last Recorded Date: Mar-2019

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Learning Objectives:
  • Understand the lifecycle approach to method development and validation.
  • Learn more about the three stages of an analytical method lifecycle.
  • Identify an Analytical Target Profile for methods being developed
  • Understand how validation, verification and method transfer are interrelated.
  • Comply with compendial requirements for verification with greater success and fewer resources.
Areas Covered in the Webinar:
  • Introduction: Using a Lifecycle Approach for Analytical Procedures
  • Stage 1: Method Design, Development and Understanding
    • Using an Analytical Target Profile to Guide Development
      • Case study
    • Using QbD Principles to Explore the Method Operable Design Space
      • Case study
  • Stage 2: Method Qualification
    • Integrating Validation, Verification and Transfer
      • Case study
  • Stage 3: Method Performance Verification
    • Using Change Control and Risk Assessment
      • Case study
  • Questions and Discussion
Who Will Benefit:

This webinar will provide valuable assistance to personnel in biotech and pharmaceutical companies/manufacturing sites, including:

  • Chemists (research and quality control personnel) involved in analytical method development, validation or transfer
  • Regulatory affairs/CMC personnel responsible for documenting analytical methods and their acceptability
  • Laboratory managers and staff
  • Analysts
  • QA/QCU managers and personnel
  • Training department
  • Documentation department
  • Consultants
Instructor Profile:
Gregory Martin Gregory Martin

Founder and President, Complectors Consulting LLC

Gregory 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 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, 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.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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