How to Set up an Internal Audit Program
Joseph Azary has spent the last 27 years in the medical device industry in various quality and regulatory positions. He is currently the Vice President of Quality & Regulatory at Z-Medica, LLC. Joseph has worked for US Surgical (now part of Medtronic), Johnson & Johnson, Fujifilm Medical Systems, and Sekisui Diagnostics. He was a consultant for 10 years where he worked with over 180 medical device companies around the world on a variety of quality and regulatory projects including 510k submissions, internal auditing, supplier auditing, quality system development (ISO 13485, FDA QSR), international regulatory registration and compliance, regulatory strategy, compliance, and training.
Joseph has a bachelors degree in Biological Sciences and a Masters Degree in Business Administration with a concentration in Public Health. He is an ASQ Certified Quality Auditor.
An overview of how to set up an internal audit program to address quality management system standards, government regulations, risk management as well as usage for continuous improvement.
This is especially useful for small to medium-sized medical device companies and start-up companies to ensure that all of the applicable regulatory requirements are incorporated into the system to ensure compliance with all necessary government regulations.
The course will discuss integrating risk-based decision making into the internal auditing program to ensure that the risks are managed and the program focuses on critical priorities. The course will also discuss how to incorporate business needs and goals into the audit program to ensure the program is consistent with the direction of the business and the goals of top management.
Lastly, the course will discuss incorporating product quality and continuous improvement initiatives into the internal audit program to help support providing high-quality products to meet or exceed customer needs.
The medical device industry continues to get more complicated as regulations increase and become more stringent. Quality management systems must incorporate a variety of quality standards and regulations from different regulatory agencies around the world, as well as incorporate good quality practices and risk management.
The changes and increase in requirements make it more challenging for companies (especially small to medium sized companies and start-ups) to set up internal audit programs.
This course gives suggestions on setting up the system to make internal audits efficient, inclusive of many different aspects and requirements as well as compliant to current standards and regulations. The course will also discuss how to incorporate risk into internal audit planning.
New ideas in regards to setting up an internal audit program and items to consider getting the most value out of the audit program.
Who Should Attend
Quality Managers and Directors, Internal Auditors, Quality Associates, Quality Technicians, Small Business Owners
Why Should You Attend
The internal audit program becomes an ever more important indicator of the health of the quality management system and regulatory compliance. Internal audits also become an important tool to manage risks for your company.
Incorporating risk, regulatory requirements, and good quality principles into the internal auditing program allow the company to address all regulatory requirements, manage risks, and ensure the necessary quality controls are adequately implemented.