Analytical Method Development and Validation
Analytical Method Development and Validation

Course Description

Regulatory guidance underpinning analytical method development and validation is changing. Regulators are now emphasising a Quality by Design (QbD) approach to analytical methods that supports their suitability for use over their entire life cycle. New update on ICH guidance on method development and validation (ICH Q14 and ICH Q2 respectively) after its publication will be discussed. The purpose of this course is to set out these new guidances in the context of other compendial and regulatory agency expectations and to help attendees avoid common mistakes during the development and validation of test methods, whether for biological or chemical drugs. Key concepts such as the Analytical Target Profile (ATP) and Analytical Control Strategy (ACS) will be explained with examples. Test methods often lack robustness because of poor documentation, which can lead to errors or high variability during routine use or method transfer. A risk-based approach to method documentation is included in the course. Each day will conclude with a workshop that will give participants the opportunity to put into practice what they have learned.
  • Life cycle management of analytical methods:
  • -- USP <1220> – Analytical Procedure Life Cycle
  • -- ICH Q14 – Analytical Procedure Development
  • -- ICH Q2 (R2) – Validation of Analytical Procedures
  • Options for test method qualification (validation, verification and transfer)
  • US FDA and EMA expectations for test method validation, execution and documentation
  • Compendial guidance on allowable changes to chromatographic methods
  • Deriving method validation acceptance criteria from the ATP
  • Important elements of the ACS
  • A risk-based approach to test method documentation
  • Designing suitable method validation, verification and transfer experiments
  • Update on current regulatory expectations
  • How to write an effective ATP
  • How to set meaningful system suitability criteria as part of the overall ACS
  • Writing method validation, verification and transfer protocols and setting appropriate acceptance criteria
  • Allowable changes to compendial chromatographic methods
  • Parameter-specific validation acceptance criteria and system suitability limits (e.g., elemental impurities and residual solvents)
  • How to avoid common errors in test method documentation
  • Dealing with method validation failure

Analytical Method Development and Validation

3 - 5 June 2024, Live Online Training
€1.850,00
Dr Mark Powell

Dr Mark Powell a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as a senior analytical chemist. Mark has served as both Honorary Secretary and Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016.

START TIMES

9:00 AM Vienna time

8:00 AM London time

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Course Description

Regulatory guidance underpinning analytical method development and validation is changing. Regulators are now emphasising a Quality by Design (QbD) approach to analytical methods that supports their suitability for use over their entire life cycle. New update on ICH guidance on method development and validation (ICH Q14 and ICH Q2 respectively) after its publication will be discussed. The purpose of this course is to set out these new guidances in the context of other compendial and regulatory agency expectations and to help attendees avoid common mistakes during the development and validation of test methods, whether for biological or chemical drugs. Key concepts such as the Analytical Target Profile (ATP) and Analytical Control Strategy (ACS) will be explained with examples. Test methods often lack robustness because of poor documentation, which can lead to errors or high variability during routine use or method transfer. A risk-based approach to method documentation is included in the course. Each day will conclude with a workshop that will give participants the opportunity to put into practice what they have learned.
  • Life cycle management of analytical methods:
  • -- USP <1220> – Analytical Procedure Life Cycle
  • -- ICH Q14 – Analytical Procedure Development
  • -- ICH Q2 (R2) – Validation of Analytical Procedures
  • Options for test method qualification (validation, verification and transfer)
  • US FDA and EMA expectations for test method validation, execution and documentation
  • Compendial guidance on allowable changes to chromatographic methods
  • Deriving method validation acceptance criteria from the ATP
  • Important elements of the ACS
  • A risk-based approach to test method documentation
  • Designing suitable method validation, verification and transfer experiments
  • Update on current regulatory expectations
  • How to write an effective ATP
  • How to set meaningful system suitability criteria as part of the overall ACS
  • Writing method validation, verification and transfer protocols and setting appropriate acceptance criteria
  • Allowable changes to compendial chromatographic methods
  • Parameter-specific validation acceptance criteria and system suitability limits (e.g., elemental impurities and residual solvents)
  • How to avoid common errors in test method documentation
  • Dealing with method validation failure

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

Analytical Method Development and Validation

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