Description :
After the Final Rule of the Quality System Regulation became effective, a moratorium on enforcement was placed for one year, until the ISO regulations went into effect for design control for medical devices. Since the design control regulations became effective, many warning letters has been issued for failures to fully implement the controlling regulations.
This webinar will focus on the records that make up the key regulatory documents, the DHF, DMR and DHR. We will discuss the effect of Change controls on the aforementioned regulatory documents, as any changes in design and production must be proposed, accepted, changes documented and verified to have no unintended consequences on the device.
This webinar is beneficial for any professional who is involved with a design effort from the time management releases funding to develop a new device design.
Areas Covered in the Session :
The Design History File (DHF)
The Device History Record (DHR)
The Device Master Record (DMR)
Change Controls
Impact of Change Controls on each
Documentation associated with each
Who Will Benefit:
Research & Development Departments
QA/QC Departments
Regulatory Affairs Departments
Quality Management Teams
Documentation Departments
Combination Products Design Personnel
Production Teams
Marketing Teams
For more information about this event please visit
https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1881
