This advanced course provides an in-depth examination of pharmaceutical auditing for individuals working in the life sciences industry. The course is designed to address the need for a working knowledge of auditing principles, techniques, and methodologies in a highly regulated industry. 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).
Through lectures, case studies, and interactive discussions, students will gain a practical and comprehensive understanding of the audit process, including conducting complex audits, interpreting audit findings, and implementing effective CAPAs. The course will also cover advanced topics such as risk management, data integrity, and supplier auditing.
Students will have the opportunity to develop practical skills through hands-on exercises and simulations, including conducting mock audits and presenting findings to a panel of experts. Graduates will have a strong understanding of how to design, plan, and conduct effective audits, including the ability to evaluate risks, identify compliance issues, and develop and implement effective CAPAs.
Upon completion of the course, graduates will have a thorough understanding of pharmaceutical auditing and will be able to perform their job responsibilities confidently.
This course is suitable for individuals who have a basic understanding of auditing principles and are looking to expand their knowledge and skills to advance their careers in quality assurance, quality control, or regulatory affairs in the pharmaceutical, biotech, or medical device industries.