The course covers facility/equipment qualification, process validation and validation of analytical methods. It covers regulatory guidance and requirements for Europe, US and elsewhere, including ICH.

This course is suitable for those working in most pharmaceutical companies e.g. those producing novel medicines, generics manufacturers, ‘virtual’ companies, suppliers/contract manufacturers, etc. It is applicable to scientists, engineers, validation professionals working in development, manufacturing, quality, support functions, engineering, validation and other related departments.

The course covers facility/equipment qualification, process validation and validation of analytical methods. It covers regulatory guidance and requirements for Europe, US and elsewhere, including ICH.

This course is suitable for those working in most pharmaceutical companies e.g' those producing novel medicines, generics manufacturers, ‘virtual’ companies, suppliers/contract manufacturers, etc.It is applicable to scientists, engineers, validation professionals working in development, manufacturing, quality, support functions, engineering, validation and other related departments.

PROGRAMME

During the two days the course will cover the following aspects:

Why validate?

International regulatory requirements, e.g. US, EU & elsewhere

Science and risk -based approaches

The 3 stages of the validation life-cycle (Ref FDA & EU)

Tools to enable effective validation such as:Understanding product and manufacturing process requirements

Importance of Control Strategy

Application of Quality Risk Management

Readiness

Process validation

Determining the number of validation batches

Qualification of equipment and utilities

Maintaining control of product life-cycle, including monitoring

Analytical validation:ICH Q2 principles

Analytical Method validation

Learning Outcomes

Understand regulatory requirements in EU, US and internationally for process validation, qualification & analytical methods

Understand the 3 Stage approach to validation and its applicability internationally

Apply tools and techniques to help clarify validation deliverables

Appreciate the importance of science and risk-based approaches to validation and alignment to ICH Q8, Q9 and Q10