Webinar 1 of 9. View Archive
About the Webinar Series
Manufacturers of finished medical devices sold in the U.S. are required to develop a quality management system appropriate for their organization, processes, and product risks. The Quality System Regulation (QSR) is both a legal requirement and a powerful set of principles that can help companies improve procedures and products, and ultimately the bottom line.
All device company employees should possess a working grasp of those aspects of the QSR and related regulations that pertain to their job responsibilities.
Simple in concept, the QSR requirements can be daunting in their interpretation and implementation. It is important not only to understand what the regulations and guidance documents say, but the rationale behind them, and the practical challenges of developing, establishing, maintaining, and monitoring quality procedures.
This 9 part QSR webinar series provides a comprehensive overview of the Quality System Regulation and related topics.
Webinar 1: The Quality System Regulation (QSR)
Friday, January 17, 2014 12:00 PM – 1:30 PM EST
Webinar 2: Design Controls
Friday, February 7, 2014 12:00 PM – 1:30 PM EST
Webinar 3: Purchasing Controls
Friday, February 28, 2014 12:00 PM – 1:30 PM EST
Webinar 4: Production and Process Controls
Friday, March 21, 2014 12:00 PM – 1:30 PM EST
Webinar 5: Corrective and Preventive Action (CAPA)
Friday, April 11, 2014 12:00 PM – 1:30 PM EST
Webinar 6: Complaint Handling
Friday, May 2, 2014 12:00 PM – 1:30 PM EST
Webinar 7: MDRs, Reports of Corrections & Removals, and Recalls
Friday, May 23, 2014 12:00 PM – 1:30 PM EST
Webinar 8: Documentation
Friday, June 13, 2014 12:00 PM – 1:30 PM EST
Webinar 9: Inspections and Enforcement Actions
Friday, June 27, 2014 12:00 PM – 1:30 PM EST
WHO SHOULD ATTEND:
- For small companies – For smaller medical device companies, where every employee wears multiple hats, these modules provide a concise, convenient, comprehensive overview of key rules that govern this regulated industry.
- For new hires – this information is a valuable supplement to in-house orientation.
- For those in transition – for people just entering regulatory or quality, or coming to devices from another regulated industry, this series introduces the unique regulatory stance on the device industry and its products.
- For those maintaining the Regulatory Affairs Certification (RAC) credential – 1.5 RAC credits are earned per webinar. 13.5 RAC credits are earned for watching the entire series.
- For all those who need to maintain training and continuing education credits: Each Single-webinar Registrant will earn 0.15 CEUs per webinar. Each Full-series Registrant will earn 1.35 CEUs
WHAT YOU WILL LEARN:
- How and why quality should be controlled by medical device manufacturers
- FDA regulatory and quality responsibilities that all employees should know
- The Quality System Regulation and related regulations and guidances
- Documentation requirements and best practices
- Principles of complaints and reportable events
- Rules and best practices for inspections
- Resources for further information