Quality Management Systems Training Course (PDA 813)

OVERVIEW

Learn the fundamentals of establishing an effective Quality Management System (QMS) and building a culture of quality within a drug manufacturing facility. This training course includes information about the comprehensive QMS approach to quality, the critical role of senior leadership, and building a quality culture mindset throughout the organization. The course will also explore the concepts of knowledge management, quality risk management, and data integrity. Practical activities will include the use of case studies, responding to inspectional observations and warning letters, conducting quality culture assessments, and evaluating data integrity risks.

LEARNING OBJECTIVES

Upon completion of this event, the attendee will be able to:

1. Describe the impact of quality and the Quality Unit (QU) on all areas of operation
2. Define the roles and responsibilities of the QU
3. Describe the foundations of an effective QMS
4. Describe the critical role of senior management in QMS
5. Explain the concept and basic principles of product knowledge and process understanding
6. Explain the basic principles of Quality Risk Management (QRM)
7. Describe how internal audits and external inspections can support an effective QMS
8. Explain the principles and best practices surrounding data integrity
9. Explain the principles of a Quality Culture mindset

WHO SHOULD ATTEND

This event is intended for professionals who are involved in drug manufacturing and quality assurance, particularly those responsible for implementing and maintaining compliance systems.

RELATED EVENTS

PDA TRI Quality Risk Management Events