Understanding and Implementation of Medical Device Quality System Regulation Requirement
Understanding and Implementation of Medical Device Quality System Regulation Requirements
• Analyze the meaning of the elements of the QSR. • Outline the FDA Quality System Inspection Techniques (QSIT) • Do’s and Don’ts during an FDA inspection • Describe the relationship between applicable standards and guidance documents
in support of FDA compliance initiatives. • Understand international harmonization efforts and their effects. • Review common auditor/inspector questions • Learn how to read FDA warning letters and recognize situations warranting
warnings for QSR deficiencies. • Map into the requirements of the QSR and establish audit evidence to support
FDA compliance. • Know when ISO 13485 compliance is required. • Provide real world examples and interactive discussion on compliance. • How can a QM-System look like? • What is the purpose of a QM-System? • Background of the ISO 13485 standard and its current revision status • Understanding of the relationship of ISO 13485 to the ISO 90001 generic QMS
standard and U.S. Quality System Regulation. • Understanding proper use of ISO 14969 • Interpret all clauses of ISO 13485:2003 • Understand the essentials of ISO 14971 - The Medical Device Risk Management
Standard • Recognize the role of management in implementing and maintaining ISO 13485 • Implications of changes, how it will affect the company and the approach of
Regulators to the proposed changes. • Sterilisation of Medical Devices and the microbiological background
Trainer: Dr. Vincent Lam
Dr. Vincent Lam is currently the manager of Medical Health Services in TUV SUD PSB Malaysia. In this capacity, he oversees the auditing and compliance activities of medical device manufacturers who are certifies by TUV SUD product service.
Dr. Lam is trained as a microbiologist and has over 18 years of experience in the medical device industry, participating primarily in quality assurance and regulatory affairs where he oversees the compliance positions of medical manufacturers.