Inspections and Audits

ARTICLES

FDA Warns BD Facility in Ongoing Lead Test Probe

The FDA issued a warning letter to Becton Dickinson for distributing adulterated and misbranded devices, among other significant GMP violations, as part of its ongoing investigation of inaccurate blood lead test results associated with Magellan’s LeadCare test systems. Read More

PRODUCTS

Setting and Measuring Quality Objectives for Medical Devices - Webinar Recording/Transcript

$287.00
Device quality must be implemented and communicated to the FDA, on pain of warning letters or worse. The rules and procedures are technical, involving both FDA rules and ISO 13485:2016. But mastery can be accomplished in only 90 minute View

Managing Cybersecurity Risks in the Medical Device and Healthcare Sectors - Webinar Recording/Transcript

$287.00
“Smart” medical devices offer juicy targets to mischief-makers, and the threat is a global one. From garden-variety hackers, to cyber-mercenaries, to nation-states bent on global chaos, devicemakers face uncharted regulatory and liability risks. View

New Direct Marking Requirements for UDIs - Webinar Recording/Transcript

$287.00
The FDA’s final guidance on UDI (unique device identification) raises as many questions as it answers. With full compliance for Class I, II and unclassified devices looming, lawyers are hard at work parsing the FDA’s language. View

Supplier Quality Metrics and Scorecards - Webinar Recording/Transcript

$287.00
The device supply chain can include hundreds of companies and stretch around the globe. Maintaining quality is a herculean task, yet the FDA requires it of you — at the risk of Forms 483, warning letters or worse. View

European Medical Device Regulations (EU MDR) - Webinar Recording/Transcript

$287.00
Devicemakers face a market upheaval in the EU. A new set of rules — the Medical Device Regulation (MDR) — will soon supplant the longstanding Medical Device Directive, forever changing how you sell medical devices in EU nations. View

The CDRH Reorganization - Webinar Recording/Transcript

$287.00
Device regulation is about to change in ways large and small, as the CDRH moves toward a total reorganization. After it’s complete, the principal medical device overseer is expected to take a total product life-cycle (TPLC) approach, whereby postmarket realizations are fed back into premarket data requirements. View

Lean Management to Improve Quality & Compliance - Webinar CD/Transcript

$287.00
“Lean management” has come to the drug and device world, improving quality, ensuring compliance and boosting profits for those who adapt its ways to the production floor. If you’re not among them yet, then listen up. View

Medical Device Calibration Program - Webinar Recording/Transcript

$287.00
Devicemakers: The quality of your manufacturing is only as good as the quality of your measuring equipment. But you can spend a fortune on metering devices and still turn out shoddy products. It all depends on how well they’re calibrated. View

How to Get IVD Approval Through CFDA - Webinar Recording/Transcript

$287.00
Marketing into Asia just got more complicated for device and IVD makers. The China FDA (CFDA) has changed the rules significantly on IVDs, and further changes are expected. Plus, lest you forget, most IVDs require clinical trials in China. View

Compliance Confidence: Strategies for a Successful Regulatory Inspection

$595.00
Order the Compliance Confidence DVD learning set and learn strategies on how to prepare for, manage and respond to the inspection process. View

Managing FDA GCP/Bioresearch Monitoring Inspections - Webinar Recording/Transcript

$287.00
Clinical trial principal investigators and sponsors have their very own dedicated team of FDA inspectors, the Bioresearch Monitoring (BIMO) program staff. Washington public policy lawyer, David Rosen, has made a study of their inspection practices. View

510(k) Change Analysis - Webinar Recording/Transcript

$287.00
On Nov. 8, the FDA is expected to issue twin final guidances revamping the device change process and determining when a new 510(k) is required. We explain it all to you ... and outfit you with tools to comply. View