Hybird Training Information

The training starts at 9.00 am UK time and finishes 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 subsequent questions and challenges

Introductory Online Module

FREE to Attend | Live & Recorded

23 August 2023 | 1:00 PM (UK)

Delivered Online

Overview of regulatory guidances

• Examine the relevant ICH guidances: Q8, Q9, Q10, Q11, Q12 Draft
• Understanding the EMA and FDA guidances on process validation
• Understand the reasoning for the requirements
• Comparison of traditional and enhanced development

Register For Module 1 | Free

There are limited spaces on module 1. If demand is high you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations.

Day 1

18 October 2023

Overview of regulatory guidances

Traditional and enhanced pharmaceutical development

• Discover how to link product and process characterisation together
• Development throughout the lifecycle

Understanding Quality by Design in Bioprocess Validation

• Understand the Quality by Design (QbD) concept
• Applying a QbD approach to validation

• • Examine the various hybrid approaches
  • How to apply QbD
  • Evaluate the strengths and weaknesses QbD
  • Assess the value it has in your organisation
  • Practical considerations of applying a QbD approach

• Examining the following in bioprocess validation
  • Target Product Profile (TPP)
  • Quality Target Product Profile (QTPP)
  • Critical Quality Attributes (CQAs)
  • Critical Process Parameters (CPPs)
• Practical exercises

Risk assessment methodologies

• Examine the different risk management methods and tools
• Fields of application
• Learn how to assess and manage risks
• Examples for Failure Mode, Effect and Criticality Analyses (FMECA)
• Practical exercises

Examine the three stages of bioprocess validation

• Examining design, qualification and validation

• • Stage 1 – Process design
  • Stage 2 – Process Validation and Qualification
  • Stage 3 – continued Process Validation
• Learn what to do and when in the development process
• Define the process and ranges

Practical exercises, group work and case studies
Interactive group exercises in the form of discussion and/or exercises are also included as part of the course to cement your knowledge.

Day 2

19 October 2023

Process characterisation and small-scale process model utilisation

• Examine how to use small process models
• Evaluating the strengths and weaknesses of a small process model
• Understand the need for qualifying to a large-scale process
• Ensuring your small-scale data is reflecting large scale production
• Examining acceptable range studies and multivariate analyses

Developing and implementing a control strategy

• Overview and of process controls
• Examples of process controls
  • Upstream Process
  • Downstream Process
• Examine the importance of the analytical method
• Developing a process control strategy including ranges
• Process control loops and hierarchy
• Control charts data analyses
• Defining process, product, ranges and limits
• Identifying critical process parameters
• Process parameter categorisation and how to validate

Process Performance Qualification (PPQ)

• Prerequisites for PPQ
• Learn how to perform a process performance validation
• Examine what studies need to be included
• Review the sampling plan
• Protocol and report requirements

Continued process verification and validation

• Monitoring performance once approval has been granted
• Examining a batch-to-batch approach to performance monitoring
• Annual product reviews
• Examine best practice for continuous process improvement

Regulatory factors

• Capturing CMC information for the regulatory dossier
• Practical advice and guidance

Practical exercises, group work and case studies
Interactive group exercises in the form of discussion and/or exercises are also included as part of the course to cement your knowledge.

Dr Margit Holzer has over 25 years of experience in the industry and worked on more than 50 different products. She is a specialist in process, product and analytical method development for biopharmaceuticals. She has extensive expertise in bioprocess in all phases of development including preclinical production, clinical production and large-scale commercial supply.

Margit began working at Boehringer Ingelheim, eventually establishing and becoming the head of the new division of manufacturing sciences. She moved on to become the Quality Director and later the Technology, R&D and Innovation Director for NOVASEP in France, before setting her own consultancy. She now assists clients in the evaluation, optimisation and development of processes, analytics and technologies including innovative ones for upstream and downstream processing and formulation.

Margit has delivered multiple courses on bioprocess validation. She has helped delegates understand the guidelines and the steps they must take to ensure their operations are compliant. Drawing on her extensive experience Margit provides numerous case studies, examples and exercises during the course.