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Biopharmaceutical Process Qualification and Validation

18 & 19 October 2022 | Hybrid | London

£995.00£1,295.00

The price is for both days | Register for Module 1 | Free

Gain the practical skills in bioprocess qualification and validation to ensure your operations are compliant

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Enrol Before | 25 August To Save £400 | 23 September To Save £200

Discount is applied to the price above. VAT, if applicable, will be added. The full price for the classroom option is £1,695 and live online is £1,395.

Course Overview

 

Biopharmaceutical manufacturing processes must be characterised, qualified and validated to ensure product safety. EMA and FDA regulators want to see evidence of an adequate control strategy for both upstream and downstream processes. Regulators also want to see that you have appropriate steps for continuous verification and validation post approval.

 

This bioprocess training course examines the ICH, EMA and FDA guidances you must follow to ensure your product is safe and compliant. You will examine the three stages of process validation, so you know what is required and how to implement it. You will have the confidence to implement a control strategy and conduct a process performance qualification. The course will also provide you with knowledge in Quality by Design (QbD), conducting risk assessments and continuous verification.

 

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 a Hybrid Training Course?

 

You decide what format is best for you. The course is delivered as a classroom (in-person) course that is also delivered online. You can decide whether you would like to attend in person or online. The price is dependent on the option.

 

We recommend visiting our website to learn more. Click here to learn more about hybrid training at Educo Life Sciences.

Register For Free Online Session

 

There are limited spaces on the introductory session. 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.

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

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 weeks after the last session
  • Full access to the Educo Post Learning Implementation Plan (PLIP)
  • A validated certificate of attendance available for you to download and file

 

Key Learning Objectives

 

  • Understand the ICH, EMA and FDA guidances on bioprocess validation to ensure you are compliant
  • Review the Quality by Design (QbD) concept and determine if it adds value to your organisation
  • Examine the three stages of process validation for biologic products
  • Gain the valuable analytical skills to conduct bioprocess characterisation, qualification and validation
  • Learn how to implement a process control strategy based on examples from upstream and downstream processing
  • Gain the skills to conduct a process performance validation
  • Learn best practice for process verification and validation post approval to maintain compliance
  • Understand how this data is used in the regulatory submission dossier

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 subsequent questions and challenges
Introductory Online Module
FREE to Attend | Live & Recorded

17 August | 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.

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Day 1

18 October 2022

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 2022 

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.

This course is aimed at professionals who work in biopharmaceutical manufacturing who are involved in process validation. These include: Bioprocess Scientists | Upstream Professionals | Downstream Professionals | Bioprocess Development Personnel | Bioprocess Engineers | Production Personnel/Technicians | Quality | Regulatory Affairs.

 

It is also relevant for professionals working in cell and gene therapy manufacturing. Margit has experience of working with CGT products.

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

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

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 Module 1
FREE to Attend | Live & Recorded

29 March | 60 mins | 1:00 Pm UK

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.

Module 2

28 April 9:00 AM UK | 90 mins

Traditional and enhanced pharmaceutical development

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

 

Module 3

28 April 10:30 AM UK | 90 mins 

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
Module 4

28 April 1:00 PM UK | 90 mins

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
Module 5

28 April 2:30 PM UK | 90 mins 

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

 

Module 6

29 April 9:00 AM UK | 90 mins 

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
Module 7

29 April 10:30 AM UK | 90 mins

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
Module 8

29 April 1:00 PM UK | 90 mins

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
Module 9

29 April 2:30 PM UK | 90 mins

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

 

 

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.

This course is aimed at professionals who work in biopharmaceutical manufacturing who are involved in process validation. These include: Bioprocess Scientists | Upstream Professionals | Downstream Professionals | Bioprocess Development Personnel | Bioprocess Engineers | Production Personnel/Technicians | Quality | Regulatory Affairs.

 

It is also relevant for professionals working in cell and gene therapy manufacturing. Margit has experience of working with CGT products.

Free Online Module and Pricing
  • Module 1 is free to attend and is delivered online and is recorded.
  • To enrol onto module 1, please submit your details in the form.
  • Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.
  • There are price tiers for this course. The dates of these are at the located above the course overview.

 

Frequently asked questions (FAQs)

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.
• In the event we do not have enough people on one of the options we will contact you to discuss switching. If for example we ask you to switch from classroom (in-person) to live online, we will refund you the difference in price.