 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 program 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. Attendees will gain a comprehensive understanding of all components of the Quality Systems Regulation from Design Controls to Process Validation and Corrective and Preventative Action Plans (CAPA).
After choosing three core courses, select one elective course that best fits your role within a QSR environment:
Core Courses (Choose Three):
- Process Validation for Medical Devices
- Overview Of FDA Regulatory Compliance For Medical Devices
- Quality System Regulation for the Medical Device & Biotech Industries
- How to Implement Risk Management Principles and Activities Within a Quality Management System
Elective Courses (Choose One):
- Design Control for Medical Device Professionals
- Medical Devices: EU Directives, Guidance, CE Marking and ISO Standard Certifications
- Software Development for Medical Device Professionals
- Reporting Failure Investigations and Process Deviations
- Effective Quality Assurance Auditing for FDA Regulated Industries
- Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries
- Writing Effective Standard Operating Procedures and Other Process Documents
- How to Prepare for a Systems-based Inspection – Understanding the FDA’s Risk-based Inspections Approach and Ensuring Compliance
- Validation of Computer Systems
- Root Cause Analysis for CAPA
CfPIE can also deliver a customized, on-site QSR certification program to fit your firm's specific needs. For more information on this program, our courses or on-site options, feel free to contact us at +1-610-688-1708 or email us at info@cfpie.com.
|
Courses by Type
Certification Programs
& Transportation
The Center for Professional Innovation & Education®