QP Quality Management Systems Online Course

Course overview:

This course explains how to establish, manage, monitor and continually improve a forward thinking modern Pharmaceutical Quality Management System that adds real-value to your organisation. The course covers current principles on Pharmaceutical Quality Management Systems (PQMS) and includes the FDA’s “Guidance for Quality Systems” and ICH Q10 “Guidance on Pharmaceutical Quality Systems”. These guidelines explain the evolving nature of QMS thinking, with a focus on organisational effectiveness and efficiency rather than just product quality and GMP. We also include the ramifications to a pharmaceutical company of the recently updated EU GMP Chapter 1 on Pharmaceutical Quality Management Systems and Chapter 2 on Personnel. These both have a major impact on the role of Top Management within an organisation.

Delegates will leave the course with a clear understanding of how to successfully integrate GMP, ICH Q8, 9 & 10 and ISO 9000 principles into a compliant, effective, efficient and continually improving QMS for the whole business, as well as the role of Quality Personnel in re-shaping quality thinking to move with the times to meet today’s business challenges.

Who will the course benefit?

This course is aimed at any trainee Qualified Person (QP) as it meets the UK QP Study Guide requirements. The course is also of value as part of Continuous Professional Development (CPD) for existing QPs – especially those who need an update on more recent thinking with regards to Quality Management Systems. In addition this course is also of value to any Quality Professional, especially those working in Quality Assurance and Quality Improvement roles, as the course provides an eye-opening view of modern quality management thinking.

Cost includes tutor marked assessments - for full details visit the main website.