Introduction to this course: 

This course covers fundamental principles of audit management in life sciences, including key concepts and best practices for establishing and maintaining effective audit systems. Explore audit types, objectives, approaches, and processes.

Who should attend: 

This course is designed for professionals working in the life sciences, QC/QA, manufacturing, regulatory affairs, auditors, compliance officers, and anyone involved in maintaining or participating in auditing quality management systems.

Learning Outcomes: 

By the end of this lesson, you will be able to:

• Recall key definitions and distinctions between audits and inspections in life sciences.

• Explain the principles and objectives of audit management systems.

• Implement audit planning techniques to prepare for various types of audits in regulatory environments.

What will I gain: 

Participants will gain a comprehensive understanding of audit management in life sciences, equipping them with practical skills to conduct effective audits and enhance regulatory compliance within their organizations.

Prerequisites: 

Participants should have a basic understanding of quality management systems, regulatory requirements in the life sciences industry, and familiarity with ISO standards and good manufacturing practices, related to audits and inspections.

Additional information: 

Course duration: 02:42:20

Course code/version (effective date): L-61/v1.0 (28/04/2023)