Who Should Attend
This three-day course is targeted toward professionals directly involved in meeting the international and FDA's Quality System Validation requirements including those in regulatory affairs, quality assurance, process development or manufacturing. To maximize the peer learning opportunity, this course is recommended for those who may have a basic understanding of the Quality System Regulation (QSR) and/or ISO 13485, including direct work experience.
This course provides regulatory/quality systems professionals, manufacturing engineers, and process development engineers with the knowledge and skills needed to comply with the process validation requirements of the FDA's Quality System Regulation, ISO 13485 and the GHTF Validation guidance N99-10 while offering information on how to implement an effective validation program. The course is also intended for medical device professionals who are responsible for performing process validation studies and ensuring compliance with regulatory requirements for validation documentation.
Typical attendees include:
- Medical Device Validation Engineers
- Medical Device Validation Specialists
- Process Engineers
- Quality Control Specialists
- Facility Engineers/Managers
- Medical Device QA/QC Managers
- Medical Device Internal Auditors
- Contamination Control personnel
- Product/Process Development personnel
- Research and Development personnel
- Medical Device Manufacturing Specialists/Managers
- Validation Managers/Specialists
- Quality Control Analysts/Managers/Specialists
- IT/IS Administrators/Directors
- Software Engineers/Specialists
- Compliance Supervisors
- System Analysts/Administrators
- Project Managers
- Manufacturing Directors/Supervisors
Due to the complexity of today's medical products, routine end-product testing alone is often not sufficient to assure product quality for several reasons. Some end-product tests have limited sensitivity. In some cases, destructive testing is required to show that the manufacturing process is adequate. In certain situations end-product testing does not reveal variations that may occur in the product which may impact safety and effectiveness.
By the end of this course, participants will learn how an effective process validation system is a critical requirement to the movement toward a risk-based approach to compliance and product safety.