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:
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
