Pre-Recorded CD Webinar
Approximately 90 minutes in length, Self Examination and Answer Key Included
Who Will Benefit:
This CD Webinar is a must-attend for medical device professionals, including:
- Compliance officers
- QA/QC/RA
- Plant engineers
- Laboratory personnel
- Operations and Manufacturing
- General/corporate counsel
Course Description:
If there’s a problem with a device, where do you draw the line between a routine servicing issue and a “risk to health” you must report to CDRH?
With the FDA cracking down on so-called silent recalls, making the wrong decision can lead straight to 483s, warning letters and even product seizures. In fact, CDRH warns devicemakers that something as simple as sending out a patch to fix a software glitch can be viewed as a reportable event.
If your medical device develops a problem, you need know how to determine if it’s a “risk to health” to avoid an already costly issue from escalating into a regulatory nightmare.
Head off 483s, Warning Letters and Product Seizures
Nearly every device maker eventually encounters a serious product problem — and FDA inspectors will be on the lookout for “silent recalls” as never before.
View and listen to this CD Webinar with our quality and compliance expert and stay proactive, making good decisions as device problems arise and prepare effectively for FDA inspections.
Content
- What events must be reported, who is the responsible party and what deadlines apply
- A step-by-step walkthrough of the FDA’s Health Hazard Evaluation form used to classify a recall
- Recordkeeping requirements that apply even if an event isn’t reportable
- 13 items that must be included with your removal or correction report
- Four crucial steps to take before the inspection, including how to produce a single file containing all the information the inspector will want
- Six keys to managing an inspection
- Dos and don’ts for clearing inspection hurdles (such as eliminating any “off- the-record” conversations)
- Real-world case study of how a company’s failure to properly report a device field correction resulted in a warning letter
- Where to send reports in the U.S., EU, Canada and Japan
Order On-Line to Own This CD Webinar: $195.00 (shipping included)