Quality Management, Regulatory Strategy and Audit Practices
Description
The objective of this module is to ensure that students understand the role and application of a Quality Management System, Regulatory Strategy and auditing concepts as they relate to the regulatory affairs profession. An overview of the key standards and regulations as they apply to regulatory strategy and audits will be achieved along with the ability to create the framework to establish, maintain and implement a QMS.
Regardless of where a medical device is planned to be sold, the Legal Manufacturer must first implement a suitable Quality Management System to meet the business and regulatory requirements. Depending on the medical device classification and the planned market, the level of controls can vary. This module will provide learning on the key QMS models that must be met and are globally recognized. Audit preparation and regulator interactions will be explored and experiences shared to deliver acceptable outcomes.
Learning Outcomes
Evaluate and Identify an appropriate QMS application to meet the regulatory business strategy and plans for market. Develop a QMS in line with ISO 13485:2016 standard and explain it's significance from a global regulatory perspective.
Compare and contrast the U.S. requirements under CFR part 820 and the globally recognized ISO 13485:2016 standard.
Design a QMS in line with device classifications and regulatory expectations, from general controls to full compliance. Demonstrate ability to create relevant QMS documents, including Quality Manual, Standard Operating Procedures, Work instructions and templates for a clean room environment.
Determine the expectations for regulatory body inspections and identify the QMS documentation to support certification inspections and device approvals.
Explain the regulatory role within the overall business context. Identify and source regulatory intelligence to ensure the team and business are well informed and QMS systems adapt to ongoing changes and expectations as necessary.