FDA QSR Training (21 CFR Part 820) for Medical Device Companies 2016 is a webinar that covers topics such as:
- 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
FDA QSR Training (21 CFR Part 820) for Medical Device Companies 2016 is intended for:
- 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
