FDA QMSR Requirements Training

• Understand how the FDA QMSR has evolved to align with ISO 13485 more closely
• Outline the structure, content & requirements of both the FDA QMSR and ISO 13485
• Understand the key similarities and differences between the FDA QMSR and ISO 13485
• Detail the specific quality management-related requirements of the FDA QMSR and ISO 13485
• Understand how auditors approach Quality Management System Audits to ensure compliance with the FDA QMSR and ISO 13485

This course would be targeted at:

• Quality Engineers
• Quality Specialists
• Internal Auditors
• Lead Auditors
• Quality Managers
• Regulatory Professionals

The Regulatory Affairs Professionals Society has approved Comply Guru (No. 1007) and recognizes this course where members will be eligible for the stated number of RAPS credits (12).

Upon successful completion, each Learner shall receive a digital Certificate of Achievement within 1 business day.

It is recommended that each Learner should have the following prior knowledge before completing this course:

• The Plan, Do, Check, Act (PDCA) cycle
• The core elements of a management system and the interrelationship between top management responsibility, policy, objectives, planning, implementation, measurement, review, and continual improvement.
• The fundamental concepts and commonly used quality management terms and definitions

There are recommended requirements for each Learner in wishing to complete any of our eLearning modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.