Internal Auditing for the Medical Device Industry

Course "Internal Auditing for the Medical Device Industry" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview: This course provides an overview of internal auditing requirements and techniques for medical device companies as a method for risk management and quality improvement.

The course will cover auditing requirements, audit planning, preparation, knowledge, auditor skills, interviews, documents and records review, objective evidence, audit report writing and corrective action.

Why should you attend?

Attendees should attend this seminar for risk management and improvement purposes to identify weaknesses, problems, compliance risks, and improvement opportunities.

Who Will Benefit:

Quality Manager
Quality Associate
Quality Engineer
Quality Technician
Regulatory Associate

Speaker and Presenter Information

Joseph Azary -- Director Regulatory and Quality at Sekisui American Diagnostica

Joseph Azary has over 25 years of quality and regulatory experience in the medical device industry. Joseph is currently the Vice President of Quality Assurance & International Regulatory Affiars at Z-Medica, LLC.

Joseph Azary has worked for companies such as US Surgical (now part of Covidien), Johnson & Johnson, Fujifilm Medical, and Sekisui Diagnostics. Mr. Azary was a consultant for 10 years working with approximately 180 companies. He has sold his consulting company, Azary Technologies in 2008.

Joseph has a bachelor’s degree in Biological Science from University of Connecticut and a Masters of Business Administration (MBA) in public health from Sacred Heart University. Joseph is an ASQ Certified Quality Auditor (CQA).