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

Instructor: Gregory Martin
Product ID: 703644
  • Duration: 90 Min
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.

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Aug-2016

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

Why Should You Attend:

This webinar is designed to provide participants with a lifecycle approach to developing and validating analytical methods, including some elements aligned with QbD concepts. By using a lifecycle approach, methods are more likely to meet their intended purpose, and scientists are more likely to have success during validation and transfer exercises.

The course will build on traditional concepts of method development, validation and transfer by introducing the Analytical Target Profile (which identifies what the method is expected to accomplish), fostering method understanding (using QbD concepts to explore the method operable region and stressing the importance of real samples in the environment where they will be tested) and demonstrating how these principles can be used iteratively as methods change location or evolve technically. This approach will be linked with current compendial requirements. There will be an opportunity for questions and answers at the end of the presentation.

The webinar instructor, a leading expert on the subject, will use his industry knowledge in presenting relevant case studies to increase participants’ understanding of the three stages of an analytical method lifecycle.

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.

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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. ComplianceOnline 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.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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