This course provides an introduction to pharmaceutical auditing for individuals interested in working in the life sciences industry. Auditing is an essential component of Good Manufacturing Practices (GMP) and is used to ensure that manufacturing processes and facilities comply with regulatory requirements and guidelines. In this course, students will learn the fundamental concepts and principles of auditing, including the different types of audits, the regulatory requirements and guidelines for auditing, and the role of the auditor in ensuring compliance with GMP.
Through lectures, case studies, and interactive discussions, students will gain an understanding of the audit process, including planning, conducting, and reporting an audit. The course will cover topics such as audit planning and preparation, audit techniques and methodologies, documentation and record-keeping, and corrective and preventive actions (CAPAs).
Upon completion of the course, graduates will have a good understanding of pharmaceutical auditing and the importance of audits in ensuring compliance with regulatory requirements and guidelines.