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Inspection and Audit Readiness Training for Medical Device Manufacturers

There is an art to effectively managing an inspection. Leveraging decades of experience from our technical experts – who have hosted numerous inspections over their careers – Oriel STAT A MATRIX has created an experiential-based workshop designed to show teams how to effectively prepare for external audits and inspections. Hands-on exercises, best-practice tips, “do’s and don’ts,” real-time role-play, practice, and constructive feedback prepare team members for the logistics of an audit or inspection, and instruct them on auditee behavior, site preparation activities, front room/back room set up, and documentation prep. Participants will also gain an understanding of auditor/investigator techniques so your team is prepared and, most importantly, has the confidence to effectively navigate the challenges that FDA and Notified Body audits/inspections present.

This course is only available as part of a nine-day Private Onsite Learning Experience that combines training and coaching with an immediate opportunity to apply new knowledge and skills.

 
After three days spent leading the inspection and audit readiness workshop, your instructor shifts to a coaching role for the next two days. At this time, you fine-tune your auditee behavior and receive detailed performance support built on what was revealed during training. This prepares you for the final part of the experience, a mock QSIT audit.. The last four days, an OSAM Leader Auditor Consultant will run the mock audit. This will uncover any nonconformances while also satisfying internal audit requirements. The initial instructor (now coach) provides support as you and your team apply your new skills and knowledge. This hands-on, guided practice audit reinforces what was taught, improving both retention and ensuring that the team is ready when FDA or your NB shows up!
 
For more information regarding this learning experience, contact us.
This private program is not available in a virtual format.

 

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Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times.
There are currently no public dates scheduled. All our courses are available to be held at a location of your choice. Please contact us for more information.

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Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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