Course offering number:0901-703
Course ID:
2245
Pharmaceutical cGMP-Quality Systems
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
Professionals in the pharmaceutical industry that engage in the manufacture, processing, packaging or holding of drug products as well as
regulatory personnel will find this course beneficial. CFR 21, Parts 211.25(a) and (b) require cGMP training on “a continuing basis for all
personnel involved the manufacture of pharmaceuticals.”
This course is for employees that have been introduced to the basic cGMP concepts and need a deeper exposure to cGMP Quality Systems.
Description
This 90-minute accredited online training course will focus on the elements, responsibilities and measurements of the pharmaceutical Quality
System, the primary system of FDA's Systems Based Inspection Program. Special attention will be paid to components of the system that are
often problematic and focused on by regulators. Identification of common tools that can be used by pharmaceutical personnel to solve
problems and the elimination of manufacturing non-compliance will be discussed.
Module 1:
• Key elements in a Quality System
• What are the key Quality Systems?
• Who is responsible for these Systems?
• What are metrics?
Module 2:
• Change Control
• CAPA - Investigation - Corrective Actions
• Validation
• Audit
• Training
• Calibration
Module 3:
• Easy ways to see if the system is broken
• Simple remedies
• The pharmaceutical workers' role in maintaining the
integrity of Quality Systems
Question and Answer Session