GXP: Quality Standards and Regulations for the Medical Device Field

Instructor: James W Monroe
Product ID: 706494
Training Level: Basic to Intermediate
  • Duration: 60 Min
This webinar will discuss and define GXP’s, where the variable “x”, is Laboratory, Clinical, or Manufacturing. The webinar will focus on the requirements for each, and how they relate to the total product lifecycle, compliance, and inspections.
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Read Frequently Asked Questions

Why Should You Attend:

If you a manufacture of Medical Devices or an Importer of Medical Devices

  1. Do you know the consequences of non-compliance?
  2. Are you ready for an FDA inspection?
  3. Are you familiar with QSIT techniques?

GxP is a set of regulations and quality guidelines formulated to ensure the safety of medical devices, to maintain the quality of processes throughout the total product lifecycle. In this webinar we will examine the x-factor. We will focus on how GXP are applied in the following areas: Traceability, Accountability, and Data Integrity. The participants will learn the critical aspects of laboratory, clinical and manufacturing practice. Additionally, the potential consequences of non-compliance, and inspections.

Areas Covered in the Webinar:

  • Good Laboratory Practices
  • Good Clinical Practices
  • Current Good Manufacturing Practices
  • International Conference on Harmonization (ICH)
  • Traceability
  • Accountability
  • Audit(s)
  • 483’s
  • Enforcement Discretion

Who Will Benefit:

  • Quality Assurance Professionals
  • Regulatory Professionals
  • Device Manufacturers
  • Auditors

Medical Device Manufacturers, Importer, Clinical Investigators, Pre-Clinical Laboratories

Free Materials:

  • GLP: 21 CFR - Title 21 CFR 58: Non-Clinical Laboratory Studies
  • GCP:
    • 21 CFR 11 – Electronic Records & Signatures
    • 21 CFR 50 – Protection of Human Subjects
    • 21 CFR 54 – Financial Disclosure
    • 21 CFR 56 – Institutional Review Boards
    • 21 CFR 812 – Investigational Device Exemptions
    • 21 CFR 814 – Premarket Approval of Medical Devices
  • cGMP: 21 CFR 820: current Good Manufacturing Practices
    • Quality Management System Requirements
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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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