Audience

Aimed at 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.

Duration

1 day

Objectives

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

Content

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.

Cost

Non-Member - £695 + VAT
One Nucleus Member* – £556 + VAT

*Please email training@onenucleus.com for the ON member discount code.

Training provided by

Tel: 0118 918 4076
Email: bookings@rssl.com