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

View Required Courses Certification FAQs

About the Certification Program

Adherence to the FDA Quality System Regulation (QSR) is often the greatest challenge facing Medical Device and Biotech manufacturers. The scope of FDA QSR is large, and non-compliance is not an option.

CfPIE’s FDA Quality System Regulation (QSR) Certified Compliance Professional (QSRCP) program provides FDA quality system regulation training and certification opportunities that meet the needs of industry professionals. The QSRCP certification program is available for individuals in the United States, Europe, Canada, Australia and Middle Eastern countries. Full List of Countries where we offer Pharma & Biotech and Medical Device Courses.

The program is ideal for 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).

Contact a Training Advisor

We offer on-site pharmaceutical training and life science certification programs for organizations with 10 or more employees enrolling. Call us today at 1-610-648-7550 or Contact a Training Advisor.

Proceed To Required Courses Certification FAQs

Certification Requirements:

Choose 3 Core Courses from any of the courses listed below.
Choose 1 Elective Course (Can be a core course or any course listed at: Courses by Title)

Advanced Topics in Biostatistics for Non-Statisticians Auditing and Qualifying Suppliers and Vendors Biostatistics for Non-Statisticians Clinical Document Management: A Trial-by-Trial Compliance Approach Computer System Validation Effective Document Management for Pharma, Biotech & Medical Device Ethics in Research - Values for Responsible Conduct of Research FDA Inspections – What Regulators Expect & How to Prepare GMP Training for the QC Laboratory Good Manufacturing Practices Training | GMP Course Human Error Prevention (HEP) - Risk Factors and Strategies Integration of Risk Management Principles and Activities into the Pharmaceutical Quality System Intro to Medical Device Submission - 510(k)s, PMAs & Exemptions

Introduction to Medical Combination Products Introduction to Statistical Analysis of Laboratory Data Marketing & Advertising of Pharmaceutical & Medical Devices Medical Device Process Validation Training for Professionals Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems Overview of FDA Regulatory Compliance for Medical Devices Overview of the New EU Medical Devices Regulations: MDR, IVDR, CE Mark and Compliance, QMS Fundamentals Pharmaceutical Root Cause Analysis of Failures & Deviations - Developing an Effective CAPA Strategy QbD - Product & Process Optimization using Design of Experiments Technical Writing for Pharma, Biotech and Med Devices US Medical Device & Quality System Regulations - Design Controls & Validation Writing Effective SOP and Other Process Documents

Certification Program Discounts

If you have 10 or more employees that would benefit from this certification program, we can offer complete program tracks on-site at your facility. For more information call us at 1-610-648-7550 or contact us.

Pharma & Biotech Courses

Medical Device Courses

Skin & Cosmetics Courses

Since 2006 CfPIE has