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Enhance your team

Is your audit team established, but sometimes there are difficulties resourcing audits?  Is your company developing, expanding or virtual, and your audit department isn't fully staffed?  Are you preparing for a regulatory inspection, and a second set of eyes to evaluate your vendors or your internal processes would be value added?  We can be your solution by becoming an extension of your audit team!  The process can be seamless, by either using your company's established process and procedures, or by using ours.  Whether the audit or consulting activities occur virtually, in person, or via a hybrid model, we have it covered.  We have the same outcome as your team: keeping your patients in mind and providing them a quality product.

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MORE ABOUT ME...

I bring over 25 years pharma industry experience, with 20 years experience specifically as a full time auditor. During that time, I've conducted pre-approval inspection audits that resulted in 10 approvals, many were first in class.  I've conducted internal and external audits throughout the world.  I'm a certified auditor:

  • Certified Quality Auditor (American Society of Quality)

  • Lead Auditor ISO 9001 (Exemplar Global)

  • Lead Auditor ISO 13485 (Exemplar Global)

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