Event Details
16 hours
Combination lecture and classroom exercises
Available on-site at your organization, at QSG’s facilities, and virtually
Black Friday Deal: 25% Of All 2024 Classes!
Use Code: BLACK FRIDAY 2024
Use Code: BLACK FRIDAY 2024
This course is designed to provide pharmaceutical professionals with the information required to prepare for and understand what will happen during a mock audit and during a Pre-Approval Inspection (PAI).
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Please contact us if you are interested in private training for this workshop.
16 hours
Combination lecture and classroom exercises
Available on-site at your organization, at QSG’s facilities, and virtually
Inspections by the FDA can be challenging and there are consequences if you do not meet the requirements. This course is designed to provide pharmaceutical professionals with the information required to prepare for and understand what will happen during a mock audit and during a Pre-Approval Inspection (PAI). For the latter, it details what the FDA looks for, among other related, in-depth topics. Mock audits are useful tools that help identify non-compliance and gaps beforehand. Furthermore, they provide an understanding of where issues lie, in order to address them proactively and effectively, before an actual inspection occurs by the FDA.
This course is designed for pharmaceutical professionals.
Through training, participants will learn:
Chris, Angelo and Barbara,
The recent meeting “What we can learn from FDA Warning Letter” was an excellent and exactly what I was looking for. Please keep me on the list for future meetings. Real professional of you folks. I have given your companies information out to an acquaintance from ASQ as a source for training for internal auditing. Looking forward to a long relationship with your team.
Hi Angelo,
Great ISO 13485:2016 Internal Auditing class, honestly the most well run and informative class I’ve taken.
Hi Angelo,
We are satisfied with the process and the report. Gordon does a good job! He is up on the regulations and what we need to focus on. I have found in past years what he points out is what comes up on the radar with the Notified Body. It helps us to be ready for the process.
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