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

Day 1

9:00 – 16:00

Review of ICH Guideline Q1A and Protocol Design

• Interpret the various ICH Guideline for stability testing
• Understand requirements for storage conditions, testing timepoints and test methods required

Review of Other Relevant Regulatory Guidelines

• Review the relevance of some other ICH Guidelines including:
  • Q2(R1) on validations of analytical methods
  • Q3A(R2) and Q3B(R2) on impurities in drug substances and drug products

Interactive Exercise 1 – Designing Protocols for Stability Studies

• Put into practice the learnings from the previous topics
• Learn how to ensure that protocols are designed for specific products and packaging systems

Principles of Degradation Chemistry

• Learn how various environmental stresses can impact the chemistry of drug substance molecules
• Understand that even for relatively simple molecules, degradation chemistry can become complex

Conducting Forced Degradation Studies

• Apply the information derived from previous presentation to design suitable approaches for meaningful stress studies
• Learn how stressed samples should be analyzed to get maximum information

Day 2

9:00 – 16:00

Reduced Study Designs

• Learn the circumstances where reduced study designs may be applied
• Understand the differences between bracketing and Matrixing
• Review the pros and cons of using reduced study designs

Climatic Zones and Designing Studies for Zones III and IV

• Understand the various climatic zones and their impact on design of stability studies
• Review the history of ICH Guideline Q1F
• Note current status of WHO Guideline

Interactive Exercise 2           – Create a Reduced Study Design

• Apply learnings of previous presentation to use reduced study designs to achieve substantial savings for a complex stability study

Evaluation of Stability Data and ICH Guideline Q1E

• Review the various approaches advocated in Q1E for reporting stability data
• Learn how to apply statistical analysis to predict product shelf life

Photostability Studies

• Learn some principles of photochemistry
• Review the ICH Guideline Q1B

Interactive Exercise 3 – Interpretation of Stability Data

• Critically review a stability summary report of real time and accelerated data
• Identify results that are indicating something is wrong
• Establish likely causes and create recommendations on how to deal with this product

Early Development Stability Studies

• Using ICH Guideline Q1A(R2) as a baseline, learn how to adapt study conditions for early development stability studies
• Learn the importance of placebo products and clinical comparators and how to set up stability studies for these products

Management of Stability Chambers

• Learn the importance of security of stability chambers and how to ensure that they function correctly
• Dealing with chamber breakdowns
• Importance of security in management of stability studies

Interactive Exercise 4 – Dealing with Problems

• This session will address some problems that arise with
  • Stability chambers
  • Aberrant results with stability samples

Geoff Carr PhD, Pharmaceutical Consultant provides training and consultancy services to pharmaceutical companies. Previously, he was appointed as Manager, Analytical Development at Patheon Inc, Canada in 2000 and progressed to Director, Analytical Development, Thermofisher Patheon until 2023. Prior to that, he held positions of Manager, Analytical Sciences at Celltech-Chiroscience, UK, Head of Analytical Development at Medgenix, Belgium and before that at Wyeth Research, UK.

Geoff originally started his career in pharmaceutical analysis at The British Pharmacopoeia Laboratory where he held several posts and was finally appointed Head of the Laboratory. His academic background is a PhD in synthetic organic chemistry awarded by University of London, UK. He has been a Member of various British Pharmacopoeia Committees, a UK representative to Committees of the European Pharmacopoeia and Member of USP Committees including a Member of the 2015-2020 Cycle USP General Chapters – Physical Methods Expert Committee.

He is the author of numerous papers, presentations at international conferences and workshops on various topics related to applications of analytical chemistry during the development of pharmaceutical products