FDA QSR Training (21 CFR Part 820) for Medical Device Companies 2016
12 Jul 2016
Webinar
Description
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
Past Events
FDA QSR Training (21 CFR Part 820) for Medical Device Companies 2016 - 12 Jul 2016, Webinar (60483)
Important
Please, check "FDA QSR Training (21 CFR Part 820) for Medical Device Companies" official website for possible changes, before making any traveling arrangements
