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CPD Hours: 7
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.
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.
This course includes the following topics:
By the end of the course you will:
We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.
Jane has over 30-years’ experience in quality assurance roles, including Quality Management positions and, encompassing a wide range of dosage forms. Dosage form experience includes metered dose inhalers, tablets, capsules, liquids, topical preparations, plus sterile products.
Process validation & qualification, including validation methods
This course provides candidates with practical tools for validation - including qualification, process validation and analytical method validation.