Validation, Verification and Transfer of Analytical Methods

28 & 29 November 2022 | Classroom | London

£1,595.00

Successfully validate, verify and transfer your analytical methods to maintain compliance and ensure reliable and accurate analytical data

Clear

Enrol before | 30 September to save £400 | 28 October to save £200

Discount is applied to the price above. VAT will be added.

Course Overview

 

Analytical methods must be validated to ensure the reliability, consistency and accuracy of analytical data. Compendial methods should be verified to demonstrate the suitability of laboratories run the method. In addition, when methods are transferred between laboratories they must be shown to be reliable.  In certain circumstances, a waiver of method transfer requirements may be justified.  Recent guidance on method validation and transfer has been produced by FDA and EMA. The USP has guidance chapters on method validation, verification and transfer, equivalence testing and statistical evaluation.  Articles in US Pharmacopeial Forum have introduced the concepts of measurement uncertainty and lifecycle management for analytical procedures, and new ICH guidance on method development and validation is expected soon.

 

This training course will help you understand the regulatory requirements for method validation, verification and transfer. It will also suggest ways to de-risk the method validation process through prior evaluation of method performance and the use of effective protocols. The course includes material to help you plan method validation and to select appropriate acceptance criteria, as well as checklists for validation protocol and analytical method contents.

 

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 both online and classroom training courses. If you have any concerns about COVID-19 before registering on to the course, please read our COVID-19 commitment.

What is Included in a Classroom Course?

 

  • Direct access to an expert trainer
  • Interactive and engaging sessions with exercises and discussions
  • Refreshments and lunch provided on each day
  • Reinforcement session delivered 4 to 5 week after the course (online) providing you with extra time with the trainer
  • A validated certificate of attendance available for you to download
  • Access to the Educo Life Sciences Training Portal before and after the course for additional learning materials
Register Your Interest

 

Register below and we will send you more information about the course.

 

Leave this field blank

By clicking submit, you agree to our Privacy Policy

What is Included in a Live Online Course?

 

  • Direct access to an expert trainer
  • Interactive and engaging sessions with exercises and discussions
  • Bitesize learning
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 4 to 5 weeks after the last session
  • Reinforcement session delivered 4 to 5 week after the course (online) providing you with extra time with the trainer
  • A validated certificate of attendance available for you to download

Key Learning Objectives

 

  • Understand the regulatory requirements for validation of analytical methods.
  • Learn how to plan, execute and document development and validation of in-house methods.
  • Be able to explain the different requirements for validation, verification and transfer of analytical procedures.
  • Understand the principles of validation of in-house methods, verification of compendial methods and method transfer.
  • Know how to demonstrate equivalence to compendial methods.
  • Understand the important qualities of stability-indicating methods.
  • Be able to select test parameters, test conditions and acceptance criteria for different analytical measurements.
  • Know how to plan, justify and document revalidation after method changes.
  • Understand important indicators of the suitability of a method for routine QC use.
  • Understand approaches for the statistical evaluation of validation test results.
  • Understanding what questions will be asked during audits and inspections and how to answer them.

Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)

Classroom Training Information

The training starts at 9.00 am UK time and finishes approximately 4:00 pm / 5:00 pm on each day. The final day may start and finish earlier to accommodate peoples travel arrangements.

Post Learning Implementation Plan (PLIP)

Pre-course

  • 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

 

28 November 2022

Regulatory Background and Requirements

 

  • FDA, EMA and international requirements (ICH Q2)
  • Method validation terminology
  • Compendial guidance on method validation, verification and transfer:
    • USP General Chapters 1033, 1092, 1210, 1224, 1225, 1226 and 1467
    • Eur. 5.21 – Chemometric Methods applied to Analytical Data
  • EU GMPs: Chapter 6 and Annex 15
  • Recent FDA and WHO method validation guidelines
  • Different requirements for GLP, GCP and GMP
  • Recent FDA and EMA enforcement action regarding method validation
  • Introduction to quality risk management (ICH Q9)

 

Preparing for Method Validation

 

  • Analytical Instrument qualification (USP <1058>)
  • Computerized data systems (21 CFR 11, EU GMPs Annex 11 and GAMP 5)
  • Validation of chromatographic data systems
  • Validation and control of Excel spreadsheets
  • Qualification of reference standards and materials
  • Evaluating method performance prior to validation

 

Validation of Analytical Methods

 

  • Developing a validation plan and SOP
  • Phase-appropriate method validation
  • Experimental approaches to method validation: accuracy, precision, intermediate precision, specificity, LOD, LOQ, linearity, range and robustness
  • Demonstrating specificity: stress studies and impurity standards
  • Dealing with validation failures

 

Verification of Compendial Methods

 

  • Scope, objectives and requirements of USP <1226>
  • Changes allowed to chromatographic methods: USP <621> and Ph. Eur. 2.2.46
  • Risk-based approach to method verification – which validation parameters should be verified?
  • Method verification acceptance criteria
Day 2

29 November 2022

Transfer of Analytical Methods and Procedures

 

  • Method transfer objectives
  • Method transfer approaches
  • Risks in method transfer
  • Writing an effective transfer protocol
  • Preparing the receiving laboratory for method transfer
  • Method transfer to new technology: HPLC to UHPLC
  • The method transfer report

 

Demonstrating Equivalence to Compendial Methods

 

  • Method validation vs. equivalence testing
  • Definition, objective and scope of alternative methods
  • Justification for the use of alternative methods
  • FDA and USP requirements
  • Equivalence testing – what and how much?
  • Documentation requirements

 

Maintaining Method Validation (Lifecycle Management)

 

  • Monitoring method performance: system suitability testing and quality control samples
  • Change control for analytical methods
  • Handling method changes pre- and post-approval
  • Revalidation of analytical methods: when, and what to test
  • Method review
  • Continuous improvement

 

Recent Developments

 

  • Lifecycle approach to analytical methods
  • Method development and validation using Quality by Design principles
  • Validation of bioanalytical methods according to the FDA and EMA guidelines
  • Measurement uncertainty

 

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, validation and lifecycle management. He has provided support to professionals and organisations so that they are equipped to validate, verify and transfer analytical methods. Mark draws on his extensive experience of 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
  • Laboratory Personnel
  • Method Development Scientists
  • Analytical Scientists
  • Validation Scientists
  • Regulatory Affairs

Most of our classroom courses are located at a venue in central London. The city has good transport links and is good place to socialise with fellow attendees. Accommodation is not included in the price. We recommend staying in a hotel within walking distance of the venue. Lunch and refreshments are included on all days where you will be able to interact with fellow peers and the trainers.

 

The course is held in the following venue:
Hallam Conference Centre, Cavendish Venues, 44 Hallam St, London, W1W 6JJ – Link to the Google Map

OR

Cavendish Conference Centre, 22 Duchess Mews, London W1G 9DT – Link to the Google Map

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.

 

Complete our contact form by following the link. Get in touch.

*

• 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.