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 Should Attend:
- Research and Development Departments
- QA/QC Departments
- Regulatory Affairs Departments
- Quality Management Teams
- Documentation Departments
- Combination Products Design Personnel
- Production Teams
- Marketing Teams
Course Director: RICK RUTHERFORD
Rick Rutherford served as an FDA Investigator for twenty-four years and was a device and biologic certified level II investigator (one of only a handful of investigators Agency wide certified at Level II in more than one program). He served as a Performance Auditor/Trainer for the Agency’s Level II internal certification of investigators and for the Accredited Persons third-party program. He was a device expert for the last several years and served in the International Inspection Cadre. His experience includes greater than 120 international medical device inspections.
Since retiring from the US Public Health Service Commissioned Corps and the US Food and Drug Administration, Rick has been active, as a consultant to medical device firms in the US and internationally, performing mock FDA audits, providing training, webinars and consultation on remediation following FDA 483 citations, Warning Letters and consent decrees issued by the FDA.
He has a B.S. in Biology and has been trained in 36 training courses in the full range of FDA regulatory coverage. His experience also includes being a US Navy Hospital Corpsman with hands-on patient care, environmental health issues and has worked in the Oklahoma State Department of Health.