(QSRCP) Quality System Regulation (QSR) Certified Compliance Professional

Adherence to the FDA's Quality System Regulation (QSR) is often the greatest challenge facing Medical Device and Biotech manufacturers. The scope of QSR is large, and non-compliance is not an option. As a result, CfPIE has designed this quality system regulation training and certification course to meet the needs of those responsible for compliance, regulatory affairs, project planning, design and development, technology transfer, R&D, QA and manufacturing in a QSR environment. FDA QSR training program attendees will gain a comprehensive understanding of all components of the Quality System Regulation from Design Controls to Process Validation and Corrective and Preventative Action Plans (CAPA).

Certification Program FAQs

Certification Requirements:

  1. Choose 3 Core Courses from any of the courses listed below.
  2. Choose 1 Elective Course from any of our other classroom courses.
Skill Level Course Name
Foundational Basic GMPs for the QC Laboratory
Foundational Design Control for Medical Device Professionals
Foundational Design Validation, Verification, and Risk Analysis for Medical Device Professionals
Foundational FDA Inspections – What Regulators Expect & How to Prepare
Advanced Integration of Risk Management Principles and Activities into the Quality System
Advanced Medical Device Process Validation Training for Professionals
Foundational Overview of FDA Regulatory Compliance for Medical Devices

If you have 10 or more employees that would benefit from quality systems training courses and certifications, we can offer complete program tracks on-site at your facility. For more information on FDA quality system courses or certification, call us at 1-610-648-7550 or contact us.

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