Process Validation - Online Training Recording

Costs

*ECA-Member:**	EUR 1690,--
*Regular Fee:**	EUR 1890,--
*EU/GMP Inspectorates:**	EUR 945,--
*APIC Member Discount:**	EUR 1790,--

(All prices excl. VAT). Important notes on sales tax.

Registration

* also payable by credit card

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Speakers

Dr Line Lundsberg-Nielsen, Lundsberg Consulting Ltd., U.K.

Objectives

With the publication of the Guidance for Industry “Process Validation: General Principles and Practices” 2011, the FDA requires a new direction. Validation is now a „Life Cycle Process” with 3 stages:

Process Design
Process Qualification
Continued Process Verification

The focus is on process knowledge and process understanding. Both should be a result of development and verified in routine production. The “magic” 3 batches are not mentioned any more. What is very important nowadays is the term „scientific sound“, and explicit statistics are mentioned. Six Sigma elements (e.g. Design of Experiments, DoE) are also mentioned directly or indirectly. There is also a stage in routine production called „continued process verification“.

With the revision of Annex 15 EU GMP Guide in 2015 the EU is going in the same direction: Validation is a lifecycle with pharmaceutical development as basis and also a stage 3 is mentioned, called Ongoing Process Verification. In Europe 3 validation approaches are now possible – traditional, continuous and hybrid.

How can the requirements be achieved?
How to fit the FDA requirements into European guidelines and vice versa?
How can process knowledge and process understanding be demonstrated on the basis of development studies?
When is a process valid now?
Which parameters can be used for knowledge and understanding studies?
How can „continued/ongoing process verification” be realised?

These questions are at the centre of this online-course.

Background

Since 1987, the FDA Guideline on Process Validation has been the basis for qualification and validation. Within the FDA programme “Pharmaceutical cGMPs for the 21st Century” there was an announcement for a revision of the guideline. A FDA Policy Guide of 2004 gave some hints to the new validation approach. In November 2008 the “Guidance for Industry Process Validation: General Principles and Practices” was published as a draft and came into operation in January 2011. That is now FDA’s „current thinking“. The chapter 1 of the EU GMP Guide gives hints for more emphasises on process capabilities and varieties within process validation also in Europe. EMA´s Process Validation Guidance and also the revised Annex 15 from 2015 takes a life cycle approach to process validation nowadays.

Target Group

The addressees of the event are qualified staff charged with or responsible for validation activities, such as commissioners for validation, heads of quality assurance, department heads, etc. It also addresses members of validation teams (e.g. engineers, chemists, pharmacists, microbiologists) as well as representatives of the plant engineering industry and consultants.

Technical Details

To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily Display.

Timing and Duration:

When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your Needs.

In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.

Please be aware: The recording does not include the Q & A sessions.

Training Course Documentation and Certificate:

The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.

Programme

Introduction

The validation life cycle

Process Validation Life Cycle, Regulatory Requirements

Setting the scene for Process Validation
Introduction to EMA’s PV guides, Annex 15, and to FDA’s PV guide
Regulatory requirements

Process Design

Process Design
Quality by Design, ICH Q8 and Q11
Quality Target Product Profile
Critical Quality Attribute
Critical Process Parameter
Design Space
Control Strategy
Continual Improvement
Link between QbD the Control Strategy and Process Design

Systems and Tools for gaining Process

Understanding and establishing the Control Strategy
Process Understanding & the Control Strategy
Quality Risk Management
Process Analytical Technology
Design of Experiments
Process Analysers
Multivariate Data Analysis

Case Study Process Design

Stage 1
Applying QbD principles to design a process for an oral solid dosage formulation
Examples of the application of DoE and PAT
Establishing the control strategy

Process Validation / Process Performance Qualification

The purpose and principles of PV/PPQ
EU’s different approaches to Process Validation
Number of PV/PPQ batches
Acceptance criteria
PV/PPQ readiness
PV/PPQ reporting and conclusion

Case Study Process Validation / Process Performance Qualification

Stage 2.1: Designing the equipment and facility qualification programme based on the control strategy
Stage 2.2: Establishing the PPQ/PV programme based oin the control strategy
Justifying the number of PPQ/PV batches
Presenting and evaluating data
Concluding the PPQ/PV activities
Proposing a stage 3 CPV/OPV Programme

Ongoing/Continued Process Verification

EMA: Ongoing Process Verification
FDA: Continued Process Verification
Statistical tools
Monitoring plan – OPV/CPV plan
OPV/CPV for legacy products

Case Study Ongoing/Continued Process Verification

Establishing the CPV/OPV programme
Application of relevant statistics during stage 3

Case Study Ongoing Process Verification Programme for Legacy Products

Establishing an OPV programme for legacy products
Defining the relevant statistical metrics
Running, evaluating and updating the programme

Wrap-up and considerations for Process Validation in a future Industry 4.0 manufacturing environment

How will process validation evolve in light of more automated and self-optimising processes
A holistic approach to validation – covering qualification of equipment, control systems, computer systems, processes and analytical technologies and methods
The role of the control strategy

Recording from 24/25 April 2023
Duration of the recording: approx. 7 h 22 min.

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