Qualification and Validation – from Requirements to Testing|company

Read about the benefits of a company courseBefore new facilities, equipment or processes are put into use in pharmaceutical manufacturing, it is important to demonstrate that they are fit for their intended purpose and deliver the expected results.In this course, we cover the requirements for qualification and validation to help you understand the purpose of these activities.You will learn what it means to demonstrate that facilities, equipment and processes are suitable for pharmaceutical manufacturing.We cover the following topics:

• The difference between qualification and validation and the purpose of these activities.
• Relevant regulatory requirements.
• An overview of all phases of qualification and validation.
• The importance of maintaining a clear link from requirements to testing, using the V-model as a framework.
• Roles and responsibilities, including collaboration with suppliers.

The course combines presentations with practical group exercises.

Benefits for employees

• You understand the difference between qualification and validation and know when each is applied.
• You gain an overview of the phases of qualification and validation – from requirements specification to testing.
• You understand roles and responsibilities, including collaboration with suppliers.

Benefits for the organisation

• Employees understand the purpose of qualification and validation and can thereby contribute to robust processes.
• Employees can create a stronger link from requirements to testing, thereby strengthening the quality of documentation.
• Employees contribute to more effective collaboration with suppliers.