Qualomics Edge
Fundamentals
of GMP
An Introduction to the Fundamentals of Medical Device Good Manufacturing Practices (GMPs)
Enroll now and take the next step in your professional journey!
Elevate your career with our course on the fundamentals of medical device GMPs; specifically US 21 CFR 820. The course touches on the similarities with ISO 13485 and compares pharma, biologic and combination product GMPs.
What’s Covered?
Medical Device GMP Fundamentals Course Outline
Introduction and background
Quality Management System Overview
Document Control
Device Classification
Management Responsibility
Management Responsibility
Quality Audits
Training and Personnel
Design Control
Production and Processing Controls
Identification
Comparison of Drug/Biologics to Device GMP
Combination Product GMP
WHO SHOULD ENROLL?
This class is designed for professionals seeking to deepen their understanding of US medical device regulations and quality systems. Whether you’re already in Quality Assurance or looking to learn more about Quality Assurance this course will provide you with the foundation you need.
The course is also great as an annual refresher or manufacturing staff that need an intro to the fundamentals or why we do what we do.
Enroll now and take the next step in your professional journey!
Quality Assurance Professionals
Regulatory Affairs Professionals
Research & Development Teams
Manufacturing Technicians
Maintenance Personnel
Senior Management
Inventors and Founders
Industry Newcomers
Warehouse & Distribution Staff
Operations Managers
Give Yourself an Edge
Cost-Effective
On-demand training reduces costs associated with traditional in-person training, such as travel, accommodation, and venue expenses.
Flexible and Convenient
Employees can access training materials at their own pace. This flexibility accomodates different learning styles and schedules.
Consistency
With our on-demand training, all employees receive the same content and quality of instruction, ensuring a consistent learning experience across your organization.
Enhanced Engagement
Our courses’ interactive elements such as quizzes and and discusion groups make training more engaging and useful.
Read to Get Started?
Register now and start learning right away!