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

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.