Internal Auditing Ensuring Regulatory Requirement Compliance Benefits Your Organization

Monday May 20, 2019
5:30 pm - 7:30 pm

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There are multiple ways a corporation could satisfy an external auditor’s questions. Some corporations chose to do what they needed to pass the requirements, only to discover a
year later that the auditor was asking the same questions and looking for follow-through.

But that QMS is only successful – useful – if management’s plan for the company is followed, and if the people charged with executing the plan can bring improvements back to the QMS. In other words, the QMS must have an internal audit system. Mari Lambert will discuss how to make that internal auditing not only useful, but also robust, so that it will continue to benefit and improve your company, whatever slings and arrows of outrageous fortune descend on you.

Speaker

Mari Lambert is Senior Quality Assurance Manager and a member of the Executive Team at Allesee Orthodontic Appliances (AOA).

AOA is part of the Danaher Corporation, and Mari brings to the company more than 20 years of experience in the global medical device industry. She holds a BS degree Business Management, a certificate in Technical Communication, and Quality Management System Internal Auditor (ISO 9001:2015), inclusive of ISO 13485:2016.

Presently, Mari is responsible for quality and regulatory affairs for design control, process validation, complaint handling, adverse event handling, nonconforming product,
corrective and preventive action, and auditing. Mari is also a corporate auditor for Danaher, auditing companies on the medical device platform.

Throughout her career, Mari has shared her passion for auditing by training teams on the process and best practices to ensure regulatory requirements are met for the following
regulations: FDA Quality System Regulation, 21 CFR Part 820, ISO 13485, Canadian Medical Device Regulation (CMDR) and Medical Device Directive (MDD), Therapeutic
Goods (Medical Devices) Regulation (TGA), Brazil ANVISA RDC No. 16. Under Mari‟s leadership, AOA was one of the first Danaher companies to achieve certification
for the Medical Device Single Audit Program (MDSAP) in 2016.

Roundtable Discussion

ASQ Pre-Meeting Presentation
Milwaukee Area Technical College (MATC)

Presentation Description: Quality Engineering Technology Associate Degree MATC’s Quality Engineering Technology degree program prepares students to become technicians who insure that products, components, materials and processes meet quality and safety standards. Quality methods are emphasized that improve business/manufacturing processes.

Presenter Bio – Dr. Kamela J. Goodwyn
Dr. Kamela J. Goodwyn is the Associate Dean of Engineering, Electronics and Architecture programs at Milwaukee Area Technical College. Kamela’s program
foci is supporting faculty development and preparing students for STEM careers to further advance diversity, innovation and excellence in the industry.