Foundations in Quality for the Life Sciences

Foundations in Quality for the Life Sciences

Issued by Northeastern University

This course presents concepts, tools and techniques for real world, on-the-job application of quality that is practical for a wide range of organizations, targeted for the application of quality in life sciences. It provides an insight into the mindset of Quality, concepts, principles, and activities involved in Quality Assurance, Quality Control, and Regulatory Compliance within the Life Sciences Industry. Emphasis is placed on understanding the “Business of Biotech”. This is a level 3 badge.

Skills

Earning Criteria

  • Explained the importance of conformance and commitment to a Quality mindset and the cost of non-conformance
  • Demonstrated familiarity with quality management and planning systems and the tools used in the daily deployment of those systems.
  • Described and evaluated the need to develop a CAPA (corrective and preventive action) plan
  • Researched and reviewed papers on quality foundations and a project management approach.