Learn an overview of medical device industry facts, types of medical device products, regulations and product market process submission.
Duration: 4 hours
Modality: Group
Participant limit: 15
Learn about the requirements associated to the ISO 13485 Standard, which are essential to the medical devices industry.
Duration: 4 hours
Modality: Group
Participant limit: 15
Learn about of the Code of Federal Regulations Title 21, Part 820, Understanding FDA Quality Management System Regulation and process to develop, manufacture and control a medical device product.
Duration: 6 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
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
Modality: Group
Participant limit: 15
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
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
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
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
Modality: Group
Participant limit: 15
Fundamentals of Pharmaceutical Manufacturing for Engineers provides engineers and other technical professionals with a comprehensive introduction to pharmaceutical manufacturing principles, regulatory expectations, and Good Manufacturing Practices.
Duration: 12 hours
Modality: Group
Participant limit: 15
This training is designed to develop the basics of technical, scientific and regulatory competencies in the field of medical device sterilization under ISO 11135 and ISO 14937 standards.
Duration: 8 hours
Modality: Group
Participant limit: 15
This training is designed to develop on a second level technical, scientific and regulatory competencies in the field of medical device sterilization, with emphasis on processes using ethylene oxide (EtO) under ISO 11135 and ISO 14937 standards.
Duration: 8 hours
Modality: Group
Participant limit: 15
This course is designed to prepare participants to assess, monitor, and improve the Quality Management System (QMS) in the medical device industry, in accordance with ISO 13485 and applicable regulatory requirements..
Duration: 24 hours
Modality: Group
Participants will learn about the important procedures and guidelines involved in preparing for and successfully completing an audit.
Duration: 4 hours
Modality: Group
Participant limit: 15
Participants will learn about the important procedures and guidelines involved in preparing for and successfully completing an FDA audit.
Duration: 4 hours
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
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.
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: 4 hours
Modality: Group
Participant limit: 15
This course aims to provide professionals with a solid understanding of change control in documentation, its importance, and its benefits in the medical industry.
Duration: 6 hours
Modality: Group
Participant limit: 15
Technical Information
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
Modality: Group
Participant limit: 15