In today’s technology rich-environment with lines blurring between devices and pharmaceutical products, organizations (sponsors) creating some type of product combining the functionality of a device with elements of drugs or biologicals often wonder how their product will be regulated. The question of whether or not the device will be regulated as a drug, a device, [...]
Posted on 21. Sep, 2016 by Rob Sims.
With US FDA CDER’s continued focused on quality metrics, our clients may be seeing a blurred line between a “qualified” individual and a “competent” individual. Lately, many UL projects have extended beyond the “basic qualifications” of GxP employees and into competency management programs that also include executives, HR, Operations, and Sales & Marketing teams. In [...]
When you talk about training, do you receive blank stares from would-be-trainees? Do people yawn when you announce a new eLearning module? There is a solution. Here are two things you can do to add some energy to your training programs and build some enthusiasm. One is for in-person classroom instruction and one is for [...]
The now-decided Brexit vote has left considerable uncertainty in its wake among companies with operations in the UK and/or EU member states about the multiple rules and regulations under which they operate. Those questions aren’t likely to be answered anytime soon, given the apparent reluctance of UK officials to trigger the two-year stopwatch of EU-required [...]
Pharmaceutical Research and Manufacturers of America (PhRMA) is not taking this election cycle lightly. Based on the emphasis candidates have placed on drug prices, the organization is prepared to spend hundreds of millions of dollars retooling their lobby machine to counteract the negative message that is being spread by both major political parties. PhRMA , [...]
Often when an in-house training is provided based on regulatory information, the focus tends to be on covering the policy and what information the employee needs to know regarding the policy. While that approach is well intentioned, it is wrong. The goal of regulatory requirements and policy is ultimately to shape the behavior of both [...]
Let’s start with a simple definition. “A combination product is a product that combines drugs, devices, and/or biological products.” While that is a great simplification of the concept, the official definition is a bit more complex. Here is the definition from the FDA website: A combination product is a product composed of any combination of [...]
Many device manufacturers struggle to stay current with FDA thinking on controlling the quality of both their product and the development process. Design Control is defined by the FDA as a basic requirement for medical devices in 21 CFR 820.30(a)(1): Each manufacturer of any class III or class II device, and the class I devices [...]
Posted on 22. Aug, 2016 by Karl Kapp.
If you are finding that your eLearning module or your classroom instruction isn’t eliciting the desired results, it might be that you failed to conduct an adequate needs assessment. A needs assessment is simply a technique or series of techniques designed to identify the root of a problem. For example, if employees are not in [...]