Scope

This training program provides a complete understanding of the current Good Manufacturing Practice requirements for medical devices as defined in the Quality Management System Regulation, or QMSR. The program explains how the regulation incorporates an international quality management standard by reference along with the FDA-specific supplemental provisions. Learners will explore the establishment, documentation, implementation, and maintenance of a quality management system for finished medical devices intended for human use.

Objective

Upon completion of this program, learners will be able to do the following:

• Identify the scope and applicability of the QMSR, including which entities must comply.
• Define key terms as they apply to the FDA’s QMSR, including finished device, component, manufacturer, and remanufacturer.
• Explain the requirements for a quality management system, including design and development, complaint handling, record controls, labeling and packaging controls, and traceability.
• Differentiate between the incorporated international standard requirements and the FDA-specific requirements that supplement or supersede them.
• Apply risk-based thinking and documentation principles to daily manufacturing and servicing operations.
• Recognize the consequences of noncompliance, including device adulteration.

Target Audience

This program is designed for the following personnel:

• Quality assurance and quality control professionals.
• Medical device manufacturers involved in design, production, packaging, labeling, sterilization, installation, or servicing.
• Regulatory affairs specialists.
• Contract sterilizers, repackers, relabelers, and remanufacturers.
• Specification developers and initial distributors of foreign entities.
• Internal and external auditors.
• Complaint handling and record management staff.

Certification Details

Learners who successfully complete the program will receive a dated, traceable certificate that provides verifiable proof of their achievement for professional records.