Description

Learner Profile:

Learners who are already in the pharmaceutical sector who wish to increase their knowledge base in cleaning validation and/or learners who are seeking access to the area of validation and who wish to upskill specifically in cleaning validation. (Candidates are likely to have completed the Introduction to Validation for the Pharmaceutical Industry course (AMC22017) if they are new to validation).

On completion of this programme the learner should be able to:

• Demonstration an understanding the fundamental principles of cleaning validation and the industry’s regulatory requirements for compliance and documentation in relation to cleaning validation

• Describe the different cleaning methods, such as manual cleaning, automated cleaning, and cleaning-in / out - place (CIP/COP).

• Understand the risk associated with noncompliance of cleaning validation standards and regulations, and the criticality of developing correct protocols, acceptance criteria, and processes.

• Identify critical cleaning parameters, including as cleaning agents, equipment, surfaces, and sampling methods.

· Understand the concept of deviations in the context of cleaning validation, including the process of identifying, documenting, investigating, and taking appropriate corrective and preventive actions (CAPA)