Audit 3.0: Audit/Auditing Fundamentals for the 21st Century


Instructor: James W Monroe
Product ID: 706495
Training Level: Intermediate to Advanced

  • Duration: 60 Min
Whether you are being audited or conducting and audit, understanding the fundamental is critical for both quality system and regulatory compliance. In this webinar we will examine the concepts of conducting audits and being the subject of an audit (internal or external).
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Read Frequently Asked Questions

Why Should You Attend:

  1. Are you a medical device manufacturer?
  2. Have you been inspected/audit?
  3. Are you required to conduct and audit?
  4. Do you have personnel with the appropriate qualifications?

Manufacturers of medical devices are required to develop devices that are both safe and effective. The quality system is the foundation for how quality is built in to the design and development of device, roles and responsibilities and compliance.

FDA 21 CFR 820 and ISO 13485:2016 both describe the requirements of a quality management system.

This webinar reviews various types of audits: internal, external, and supplier, principles of conducting and audit, preparing for internal/external audits, and FDA enforcement.

Areas Covered in the Webinar:

  • Desk Audit
  • 1st, 2nd , 3rd Party Audit
  • Supplier Quality Audit
  • Audit Planning
  • Audit Team
  • Audit Report
  • Inspections
  • Enforcement, and Criminal Investigations

Who Will Benefit:

  • Medical Device Manufactures
  • Quality Assurance Professionals
  • Regulatory Affairs Professionals
  • Consultants
  • US Agents
  • Authorized Reps

Free Materials:

  • FDA Guide to Inspections, Compliance and Criminal Investigations
  • Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers – Part 1: General Requirements
  • Greenlight Guru - Complete Guide To Bringing A Medical Device To Market
  • FDA Inspections Operations Manual: 2016
Instructor Profile:
James W Monroe

James W Monroe
President and CEO, Global RQC Med Device Solutions

Over the past 20 years James has been exclusively involved in the medical device field focusing on Regulatory Affairs and Quality Assurance. Within this arena he has focused on getting medical devices registered globally. His background and track record demonstrates his leadership, from product concept through obsolescence, by (1.) ensuring regulatory compliance, (2.) providing strategic, tactical and operational direction and support for working within the regulations to expedite the development of safe and effective products, (3.) preparing/submitting submissions and managing communications with the Regulatory Bodies, and (4.) keeping up-to-date with changes to the regulatory environment, science and technology, the medical device industry and the healthcare sector through regulatory intelligence.

His regulatory focus is to develop and execute regulatory strategies for client domestically and internationally. He has successful gain multiple 510(k) clearances in the US, and approvals in the EU, Canada, South Korea, and Japan. He is at the forefront of regulatory intelligence staying abreast of the ever-changing medical device requirements globally. His device specialties include but are not limited to: Electro-mechanical and software driven devices, in-vitro diagnostics, digital health (Software as Medical Device, Artificial Intelligence, Machine Learning, Cybersecurity), and Risk Management.

He also holds both a Bachelors and Masters of Electrical Engineering. His Post-Graduate studies were conducted in the Department of Radiology at The Ohio State University where he developed hardware and software applications for the MRI systems and accessories. He has published multiple peer reviewed papers on image processing of medical images for image improvement.

He has held several leadership positions within regulatory and quality including: Director of Regulatory and Clinical at Pharmatech Associates-Medical Devices, Director Regulatory, Pentax Medical, Director of Regulatory & Quality at Immacor Inc., Interim Director at Convatec Inc., Manager of Regulatory at B. Braun Medical. In his role as a consultant he has worked globally with clients as the key regulatory expert responsible for developing regulatory strategies and gaining approval/clearance in multiple countries. He has also served as a 3rd party reviewer for the FDA’s 510(k) program at Intertek.

He has received clearance of over 35 510(k)”s, o f which 90%, involved software. More recently he has focused his regulatory experience in the area of digital health that includes: Software as Medical Device, Artificial Intelligence, Machine Learning, Cybersecurity, and Risk Management. He has also served as a 3rd party reviewer for the FDA’s 510(k) program.

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