GxP Auditing Logistics and Inspection Readiness Training Course (Including Mock Activity) (PDA 298)

OVERVIEW

This comprehensive training course is designed for pharmaceutical manufacturers and pharmacists who want to deepen their understanding of the auditing process. Participants will gain essential insights into how audits are conducted within the pharmaceutical industry, focusing on compliance with regulatory standards, quality management, and risk assessment.

The course will combine informative lectures with practical, hands-on exercises to ensure participants can confidently navigate the audit environment. Attendees will learn the roles and responsibilities of auditors, what they examine during audits, and the key areas of focus, such as documentation, procedures, and regulatory adherence. Through role-playing scenarios, participants will have the opportunity to participate in the audit experience helping them develop critical skills in audit preparation, communication, and reporting.

LEARNING OBJECTIVES

Upon completion of this event, participants will be able to:

1. Describe current sponsor and FDA practices expected during audits and inspections.
2. Discuss how regulations and guidance are applied to improve audit and inspection readiness.
3. Explain the differences between audits and inspections, sponsor responsibilities in relation to the FDA.
4. Identify risks in clinical trials that will be issues during a sponsor audit or FDA inspection.

WHO SHOULD ATTEND

This event is intended for professionals who wish to enhance their audit preparedness and improve their ability to manage or undergo audits in the pharmaceutical sector.

RELATED EVENTS

PDA Quality and Compliance Training Courses