FDA QSR Training (21 CFR Part 820) for Medical Device Companies 2016

Topics

• Understand the importance of written, executable and enforceable policies and procedures
• Understand the regulatory environment, FDA and industry`s history with cGMP`s
• Review of all subparts of the QSR (Subpart A-Subpart O)
• Critical and key sections and having a clear understanding of the QSR
• Why FDA`s "umbrella" approach is important for a small start-up vs a bigger device OEM
• Interpretation and applicability of the QSR
• Understand the importance of good housekeeping for both the facility and documentation management system
• FDA`s Quality System Inspection Technique (QSIT) and strategy for inspecting device manufacturers and latest trends with enforcement actions
• The Quality System Regulation and related regulations, guidance documents and other resources
• FDA regulatory and quality responsibilities that all employees should know
• Documentation requirements and best practices

Who should Attend

• CRO`s
• All levels of management and departmental representatives and anyone who desires to better understand or a "refresh" overview of QSR
• Clinical Affairs
• Regulatory Affairs/RA Specialists
• Quality Control/Quality Assurance
• Project Leaders
• Marketing & Sales
• Compliance
• Engineering/Technical Services
• Distributors/Authorized Representatives
• Research and Laboratory Operations
• Consultants
• Auditors
• Manufacturing
• Personnel who require a general understanding of the FDA`s Medical Device GMP regulation – 21CFR Part 820
• Servicing and Repairs