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Introduction to Validation

13 September 2018, Reading, United Kingdom


Introduction
Course Overview

The course provides an overview of the concept of qualification and validation as described in Annex 15 to Eudralex Volume 4.

It covers responsibilities and terminology (qualification, validation and verification), and looks at the requirements of equipment qualification (IQ, OQ and PQ), process and cleaning validation, analytical method validation. The need for effective change management and lifecycle management will be discussed. The course also examines the documentation and project management aspects of validation studies.

Suitability

This course will be of value to all pharmaceutical professionals, including management, laboratory and manufacturing staff, and engineering personnel, who need to understand the current GMP expectations of validation in today’s regulatory environment.

Learning Outcomes

By the end of the course you will:
  • Understand the regulatory expectations
  • Know how to evaluate validation and qualification requirements
  • Be able to plan and document validation studies
  • Understand the link to change management and ongoing lifecycle management
Speakers
Venue
Reading Scientific Services Limited (RSSL)

RSSL Training Suite, Reading Scientific Services Limited (RSSL), Reading Enterprise Centre, Earley Gate, Whiteknights Road, Reading, RG6 6BU, United Kingdom

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