Course Overview

This course introduces the participants to the quality systems used to meet the regulatory requirements for developing, testing, manufacturing, and selling medical products in the global marketplace. It provides a general background for all employees in the medical products field, but it is especially useful to participants preparing for a career in the Regulatory Affairs or Quality Assurance departments within a pharmaceutical, biomanufacturing, or medical device company.

Learning Outcomes

At the end of this course, participants will be able to:

• Describe what a medical product is and its uses
• Provide a full description for a medical product lifecycle
• Identify differences between various regulatory agencies including EMA, FDA and others.
• Describe clinical trials and Clinical Trial Material (CTM)
• Identify requirements for product and process controls.
• Provide sufficient documentation to claim product shell life
• Be capable of submitting formal requests for regulatory approval to obtain regulatory approval.

Who should attend?

The course is intended for participants interested in global regulatory affairs, e.g. employees in the medical products field, especially at the entry stage to a career in the Regulatory Affairs or Quality Assurance departments within a pharmaceutical, biomanufacturing, or medical device company 

Prerequisites

This course is for individuals with background, skills, and/or experience in the following areas:

• New employees in biomanufacturing, including scientists, engineers and operators
• Support personnel who are directly or indirectly involved with the manufacturing process
• Suppliers and vendors of technical equipment used in biomanufactoring
• Workers who are entering to the biomanufactoring industry.