If you work in any industry that requires FDA guidelines be followed, you will at some point have to face a dreaded audit. Completing that audit successfully is critical to the success of the business, and that means knowing all the ins and outs of what is required to prepare for and go through the audit process. Whether you are brand new to this role, or you’ve been doing quality assurance and monitoring for many years, CfPIE’s FDA audit preparation courses can help you learn how to prepare for inspection.
Establish and Maintain a Robust Quality Control System Before Your FDA Audit
One thing you’ll learn in our courses is that the best way to handle an FDA audit is to already have a great quality control system in place. You can learn how to utilize the best inspection management techniques before your audit ever takes place, so that you don’t run the risk of being deemed noncompliant during an inspection.
Prepare for the FDA Audit Correctly
Did you know that an inspection requires quite a lot of very specific actions to take place? If you are brand new to quality management, you may not be aware that the entire building being inspected needs to be performing in a certain way. The standard operating procedure during an audit should include things like ensuring that all FDA requests are documented. If you don’t know the best way to prepare a building for an FDA audit, our courses can help you create a system.
Responding to Findings After an FDA Audit
Of course, the goal is for there to be no findings during the audit – but that is not often the case. So the next step in an FDA audit is to respond to those findings in the correct way, and have the necessary documentation ready to go to implement any changes.
CfPIE’s Audit Courses Can Help You Prepare for an FDA Audit
CfPIE offers professional courses for many roles that would be part of an FDA audit process. For example, quality managers and regulatory professionals who want to prepare for a QA audit will find our course on Effective Internal and External Quality Assurance Auditing for FDA Regulated Industries extremely helpful. With this course, you will learn what is involved with both internal and external audits, how to implement them, and how to get the best results from these types of audits.
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