Course Scope
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.
The course introduces the concept of validation to the delegates. It covers responsibilities and terminology (validation versus qualification), and looks at the requirements of equipment qualification (IQ, OQ and PQ), process and cleaning validation, analytical method validation. The course also examines the documentation and project management aspects of validation studies.
Learning Outcomes
By the end of the course you will:
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Understand the regulatory expectations
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Know how to evaluate validation and qualification requirements
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Be able to plan and document validation studies
