Medical Device Quality System Design Control Master Class
ARV today announces a series of seminars on medical device and pharmaceutical compliance and quality assurance. The series will begin with the medical devices quality system design control master classes. This will surely be the premier medical device complaince training course of the year.
The Seminar Director is Dr. Kaiser Aziz a former Director of the US FDA Materials Science and Mechanics Laboratory.
Dr. Azizi was manager of drug and device evaluations, approvals, reengineering, standards, good manufacturing and quality system applications. In his 29 career with the FDA Dr. Aziz was also Chief of Clinical Chemistry and was a member of the award winning FDA re-engineering team that developed the Quality System Inspection Technique (QSIT).
If you would like to receive conference updates email: firstname.lastname@example.org. Seminar Dates and timing to follow.
The medical device master class series of seminars has been developed for all levels in medical device and combination products organisations. It is developed to give you insight into quality system/design control aspects of the medical device pre-market approval process and through out the total product life cycle (TPLC). This course is for those who require a knowledge of the FDA’s medical device evaluation program. It is a must for all operations, manufacturing and quality personnell.Series A: Medical Devices Quality System Design Control Master Classes
Master Class 1
1. FDA and Medical Device Regulations
2. Medical Device Evaluation Programs
3. FDA QSR/GMP & QSIT Inspections
4. Role of Device Design in the Total Product Life Cycle (TPLC)
Master Class 2
5. Implementation of Design Control Procedures
6. Six Sigma, Safety and Risk Management
7. Software Consideration, Validation and Verification Development and Testing
8. Software Hazard Management (System Risk Analysis vs. Software Hazard Analysis)
Master Class 3
9. Manufacturing Process Controls
10. Integrating Quality Procedures in Design Control
11. Effective Protocols and Standard Operating Procedures
12. Post-market Surveillance
Who Should Attend:
Compliance/ Regulatory Affairs -Product Development -Manufacturing Supervisors-QA/QC Personnel-Risk Management Staff-Validation Scientists and Engineers-Pharmaceutical Scientists-Clinical Drug Research and Development Staff-Consultants-Industry training personnel
Attendees shall recieve detail course notes and a certificate of attendance.
© 2008 ARV Excellence Ltd.
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