Course Scope:
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, and analytical method validation. The course also examines the documentation and project management aspects of validation studies.
Overview:
At the end of the course you will:
鈥nderstand the regulatory expectations
鈥now how to evaluate validation and qualification requirements
鈥e able to plan and document validation studies
Who should attend:
The 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鈥檚 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, and analytical method validation. The course also examines the documentation and project management aspects of validation studies.
Overview:
At the end of the course you will:
鈥nderstand the regulatory expectations
鈥now how to evaluate validation and qualification requirements
鈥e able to plan and document validation studies
Who should attend:
The 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鈥檚 regulatory environment.
