Lifecycle Management of Analytical Methods

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Course Overview


Regulatory agencies expect pharmaceutical companies to have procedures in place to ensure suitable levels of reliability, accuracy and precision of analytical test methods. The management of analytical methods should cover lifecycle phases including design, development, validation and routine use.


Recently, managing analytical methods and procedures according to the lifecycle approach has been recommended in FDA and USP documents. The FDA guidance “Analytical Procedures and Methods Validation for Drugs and Biologics” contains a section on lifecycle management of analytical procedures. This training course will examine the new analytical procedure lifecycle guidelines. After completion you will have the knowledge and practical skills to implement recommended approaches.


With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.

Key Learning Objectives


    • Learn about the regulatory background and recommendations for lifecycle management of analytical methods.
    • Understand current and future industry trends: the concept of lifecycle management of analytical methods, recent ICH guidance (ICH Q12), draft USP General Chapter <1220> (Analytical Procedure Lifecycle) and Quality by Design (QbD) principles for method development and validation.
    • Learn how to plan, execute and document the design, development and validation of in-house methods.
    • Understand the principles of lifecycle management for compendial procedures and method transfer.
    • Gain the practical knowledge to develop a strategy for analytical procedure lifecycle management.
    • Understand risk management strategies throughout the procedure lifecycle.
    • Appreciate the concept of measurement uncertainty.
    • Be able to justify and document decisions about type and extent of revalidation after method changes.
    • Have the competence to define and demonstrate FDA, EU, USP and ICH compliance to auditors and inspectors.
Post Learning Implementation Plan (PLIP)


  • Access to the Educo Training Portal
  • Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

  • At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

  • Delivered 3 to 4 weeks after the training
  • It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges
Day 1

Regulatory background and guidance

  • The importance of analytical procedures
  • Introduction to lifecycle management of analytical methods
  • USP approach for lifecycle management: proposed General Chapter 1220
  • Learnings from the new FDA, WHO and PDA method validation guidelines
  • Linking the procedure lifecycle to the quality system
  • The importance of risk management (ICH Q9)
  • Lessons from recent FDA Warning Letters
  • Recommendations for risk-based implementation


2015 FDA Method Validation guidance

  • Scope and regulatory status
  • Recommendations for integrated procedure lifecycle
  • Expectations for quality risk assessment, Quality by Design (QbD), Multivariate experiments, system suitability testing, statistics, knowledge management
  • Equipment operational qualification and trend analysis
  • Revalidation vs. ongoing evaluation


Preparing your laboratory for compliant validation studies

  • Analytical Instrument qualification
  • 21 CFR Part 11/Annex 11 compliance of computer systems
  • Validation of chromatographic data systems
  • Validation and control of Excel spreadsheets
  • Qualification of reference standards and materials


Lifecycle overview: method development, validation, and ongoing performance verification

  • Advantages of the new approach
  • Key steps for design, development, validation and ongoing performance verification
  • Integrated lifecycle and QbD: similarities, differences
  • Regulatory status of the new approach
  • Integrating method transfer and compendial method verification
  • Application of risk management through the life cycle


Day 2

The analytical target profile

  • Comparison with the scope of current methods
  • Advantages and limitations of the ATP approach
  • Introduction to measurement uncertainty
  • Target measurement uncertainty (TMU)
  • Considerations for establishing an ATP
  • Incorporating current USP, ICH and FDA guidance into the ATP
  • Constructing an ATP for existing methods


Method Design and Development

  • Knowledge gathering: what and how
  • Risk management: assessment, evaluation and control
  • Analytical control strategy
  • Typical control examples
  • Illustration of controls using Ishikawa (fishbone) diagrams
  • Knowledge management as an important factor in ensuring the acquiring, analysing, storing and disseminating information


Performance Qualification (Validation)

  • Developing a validation/qualification plan and SOP
  • Going through ICH Q2 validation and test parameters:
  • Accuracy, precision, intermediate precision, specificity, LOD, LOQ, linearity, range, robustness
  • Examples for design and execution of test experiments
  • Examples of application-specific acceptance criteria
  • Evaluation of test results: using statistical models


Ongoing Performance Verification

  • Objective of ongoing performance verification
  • Monitoring method performance: system suitability testing and quality control samples
  • Handling of method changes vs. permitted adjustments
  • Revalidation of analytical methods: when, what to test
  • Handling of out-of-expectation results
  • Continuous improvements

Dr. Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over 30 years’ experience as an analytical chemist. In 2003, he helped to set up a UK-based contract research and manufacturing company specialising in early-stage drug development, where he ran the analytical development programme. His responsibilities included commissioning and validating laboratory data systems and training staff.


In 2013, he set up his own company which offers training and consultancy services to the pharmaceutical industry. These include guiding the CMC aspects of drug development programmes and training in areas such as chromatography, dissolution testing, data integrity, method development/validation, analytical instrument qualification, technical writing and auditing.


Mark has delivered many training courses on analytical method development and lifecycle management. He has provided support to professionals and organisations so that they understand the latest FDA and ICH guidelines on lifecycle management of analytical methods. Mark draws on his extensive experience of product development, method development and validation and provides multiple examples throughout the course.

This course is aimed at professionals who are responsible for the development and maintenance of analytical methods. These include: Quality Assurance Personnel | Quality Control Professionals | Method Development Scientists | Analytical Scientists | Validation Scientists | Regulatory Affairs.

Could your team benefit from this course?

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.

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• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• For live online courses, dates and times of modules are subject to change
• Please contact us for the module dates of future deliveries.
• For live online courses, module durations are approximate.