Learn about of the Code of Federal Regulations Title 21, Part 820, Understanding FDA Quality System Regulation and process to develop, manufacture and control a medical device product.
Duration: 4 hours
CEUs: 0.5 hours
Modality: Group
Participant limit: 15
The course focuses on developing skills to identify and understand the main issues in different situations, organize information, and improve the ability to summarize information concisely and clearly to express ideas effectively.
Duration: 6 hours
CEUs: 0.7
Modality: Group
Participant limit: 15
Learn about the key elements of Good Documentation Practices for the medical device industry and their application in managing documentation and records.
Duration: 4 hours
CEUs: 0.5 hours
Modality: Group
Participant limit: 15
Learn about the key elements of Good Manufacturing Practices for the medical device industry involved in the manufacturing of medical products.
Duration: 4 hours
CEUs: 0.5 hours
Modality: Group
Participant limit: 15
The course focuses on providing the student with a basic understanding of design controls for medical devices according to international regulations and standards.
Duration: 4 hours
CEUs: 0.5 hours
Modality: Group
Participant limit: 15
Learn an overview of medical device industry facts, types of medical device products, regulations and product market process submission.
Duration: 4 hours
CEUs: 0.5 hours
Modality: Group
Participant limit: 15
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Learn the key concepts and fundamentals associated with the process validation cycle, such as VMP, EQ, TMV, OQ and PQ, and the correlation with regulations and standards.
Duration: 4 hours
CEUs: 0.5 hours
Modality: Group
Participant limit: 15
Introduction to Statistics is a practical course that provides students with a hands-on understanding of basic statistical tools.
Duration: 4 hours
CEUs: 0.5
Modality: Group
Participant limit: 15
Learn about the requirements associated to the ISO 13485 Standard.
Duration: 4 hours
CEUs: 0.5 hours
Modality: Group
Participant limit: 15
This course provides an overview of the medical device industry, addressing product types, common regulatory concepts, applicable regulations and good manufacturing practices, with emphasis on basic packaging concepts and the sterilization process to ensure compliance with applicable regulations.
Duration: 6 hours
CEUs: 0.7
Modality: Group
Participant limit: 15
This course provides a comprehensive introduction to modern manufacturing systems, blending historical context with current methodologies and hands-on application.
Duration: 15 hours
CEUs: 1.6
Modality: Group
Participant limit: 15
The objective of this course is to level and harmonize risk management knowledge for the entire population using risk documents within the context of the medical device industry.
Duration: 9 hours
CEUs: 1.0
Modality: Group
Participant limit: 15
