Hybrid Training Information

The training starts at 9.00 am UK time and finishes at approximately 4:00 pm / 5:00 pm on each day. For classroom attendees, refreshments are served from 8:30 AM. For online attendees, you will receive joining instructions.

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 2023

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 2023

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.