Course offering number:1009-705
Course ID:
2418
What is the Pharma Quality System and Why Should I Care?
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This online training course is intended for professionals in the Pharmaceutical industry. It will be especially valuable to the following individuals
and disciplines:
• Executive managers (CEO, COO)
• Senior managers
• Middle managers
• Quality managers
• Quality Assurance
• Regulatory
Description
In 2001 the US FDA began using a system based approach to inspections and one of the systems listed in the inspectional guidance is the
Quality System. In 2004 the FDA issued: Guidance for Industry - Quality Systems Approach to Pharmaceutical CGMP Regulations as a draft
guidance. It was finalized in 2006. Then in May, 2007 the ICH published ICH Q10, Pharmaceutical Quality System, which was revised in June
2008. The FDA is encouraging the pharmaceutical industry to implement Quality Systems, yet it is not clear what constitutes a Pharmaceutical
Quality System.
This 90-minute accredited training will discuss the concept of a quality system and how the FDA guidance, ICH guidance and other quality
standards relate to one another. Elements of a Pharmaceutical Quality System will be delineated and a framework for the PQS suggested. In
addition to the course notes handout, relevant material including the ICH Q10 FDA Guidance will be included for download.
Module 1: What is a Quality System
• The Quality System in FDA Systems
Inspection
• FDA Guidance on the Quality System
Approach to GMPs
• ICH Q7
• Quality System vs. Quality Management
System
• ICH Q10- Pharmaceutical Quality System
• Other Quality Systems
Module 2: What is a Pharmaceutical
Quality System
• The System as described in ICH Q10
• Management responsibilities
• Product Lifecycle
• PQS elements
• Enablers
Module 3: What should be in a
Pharmaceutical Quality System
• Suggestions from the Quality System
Guidance
• CGMPs
• Contemporary elements
Where to start when implementing the
Pharmaceutical Quality System
• Identify organizational needs
• Select a framework
• Transition from current state to the desired
state
Question and Answer Session