ASQ Palomar Section 10 March meeting: Nancy Pasquan
The presentation covers the commonalities between various audit types and then discussed how each type is different from the others. The types covered are ISO certification, Supplier Qualification, Mock FDA, For Cause, Internal, and Data Integrity. Also included will be tips for conducting remote audits.
Nancy Pasquan Bio:
Nancy is currently performing ISO 13485:2016 certification audits, supplier assessments and internal audits across a wide range of manufacturers and service providers. She has over 30 years’ experience in software systems development, maintenance, and management on pharmaceutical, medical device, clinical, military and commercial projects. She spent years providing computer system validation services and training to medical device and pharmaceutical companies.
She holds a BS in Computer Science, is past Secretary of the ASQ Software Division (through 2019), past treasure of the San Diego section (703), and served on the board of the San Diego Society for Software Quality. Nancy travels whenever the opportunity arises and can otherwise be found wandering around in the San Diego sunshine.