Commercial Operations

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FDA’s NEST Program and Real World Evidence - Webinar Recording/Transcript

$287.00
The FDA is working on simplifying the evaluation of new medical devices via Real World Evidence (RWE). The FDA initiative is known as NEST (National Evaluation System for Health Technology) … and it could benefit you. View

Nine-Volume Title 21 CFR Set 2018

$585.00
The federal government has compiled the new 2018 CFR volumes.






View

Investigations Operations Manual 2018

$377.00
Don’t wait for FDA investigators to tell you what their new focus is when they’re already at your facility. Get a heads up with Investigations Operations Manual 2018. View

Advertising & Promotion Hot Topics in Today’s FDA and FTC Landscape - Webinar Recording/ Transcript

$287.00
Drug and device advertising, marketing and promotion has come a long way from 30-second TV spots. These days the cutting edge is social media, product placement, engaging influencers, reality TV, pop-up shops and more. View

Supplier Quality Metrics for Devicemakers: Predicting and Selecting the Best

$397.00
In the Supplier Quality Metrics for Devicemakers management report you’ll learn how to use predictive analysis of such metrics as delivery time, management efficiency and lot acceptance rate to identify suppliers you can count on and spot potential problems in the future. View

Top Tips for Dealing with the FDA - Webinar Recording/Transcript

$287.00
The FDA is an inescapable presence in your life. It can be supportive and helpful one day, then turn on a dime and make life quite difficult indeed. But you have a say in the matter. You can control this all-important relationship to your advantage. View

Advertising & Promotion - Webinar Recording/Transcript

$287.00
Drug and device makers must advertise to survive, but the legal issues surrounding advertising and promotion are far from settled. FDA enforcement actions don’t seem to show a consistent pattern, leaving you to guess whether a warning letter lurks ahead and how to avoid it. View

Meeting the Competence, Training and Awareness Rules for Medical Device Manufacturers - Webinar Recording/Transcript

$287.00
Device manufacture is a complicated business, but few areas are more rulebound than QMS. Many a devicemaker has come up short trying to stay abreast of the FDA’s QSR, ISO 13485:2016, and other ISOs while trying to comply with competence, training and awareness rules. View

Getting Real About Real World Evidence - Webinar Recording/Transcript

$287.00
Real world evidence — “RWE,” so-called — is making its way into your world. Sonali P. Gunawardhana Esq., one of the sharpest legal minds to emerge from the FDA in recent years, and Dr. Mary Jo Lamberti, a faculty member at Tufts CSDD, will walk you through the fast-moving RWE changes currently affecting the agency and business decisions alike. View

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