Live eLearning - PDA 113.1 Establishing and Implementing an Effective GMP Auditing Program

The role of the GMP auditor can be one of the most challenging ones in the pharmaceutical, biopharmaceutical and medical device industries. Performing an independent assessment of operations, identifying areas of potential concern, and ensuring appropriate and effective corrective actions are taken is critical to ensuring firms maintain a solid compliance posture and that management is aware of any potential compliance concerns.

This training course is designed to give participants an understanding of the value in identifying the perils and pitfalls in establishing and running an effective GMP audit program and ways to overcome them. The unique challenges associated with supply chain auditing will also be addressed. The training course will be interactive, using a combination of lecture, case studies and small group discussions. Participants will develop an audit plan and supporting documentation during the session. Attendees will prepare an audit report using examples of actual audit findings provided by the trainer.

At the conclusion of the training course, participants will have a better understanding and awareness of why an audit program is necessary, how it should be constructed, operated and maintained, as well as an appreciation for the most effective ways to communicate and follow up on audit findings.

1. Identify common perceptions and misperceptions associated with GMP auditing and how to address them
2. Develop effective audit plans and prepare and use documentation to support the audit process
3. Identify different types of audits and determine where and when to use them
4. Prepare and deliver effective audit reports to appropriate levels of management and conduct effective follow up
5. Examine the unique challenges associated with supply chain auditing and develop strategies to address them