EG Life Sciences

Is your company as far along as it needs to be?

The In Vitro Diagnostics Regulation, or the IVDR, was created to ensure a greater level of patient protection and regulation around the creation of in vitro diagnostic devices (or IVDs). The IVDR will replace the legacy In Vitro Diagnostic Directive (IVDD) and should ensure a greater level of patient protection and provide rules and regulations that are more effectively implemented.

The manufacturers of these devices are well aware of the IVDR that will soon take effect. Most of these manufacturers are already taking the necessary steps to prepare to comply with this new regulation, but are they as far along in their preparations as they should be?

Your cold room just went down. Now what?

What are Net Promoter Scores?

Have you heard of Net Promoter Scores? A company’s NPS or Net Promoter Score is a measurement of customer satisfaction.¹ These scores are especially useful in the staffing industry, in which feedback isn’t linked to a tangible product, but is instead related to a more subjective service or experience. For example, when a client says their experience with us was “good,” it’s difficult to derive true meaning from that response, especially as the definition of “good” likely varies vastly from client to client. Thus, the staffing industry was in need of a universally understood, tangible measure of a subjective experience. Enter NPS. While NPS surveys can ask a number of questions, the concept truly focuses on only one:

How likely are you to recommend your firm to a friend of colleague?²

When the FDA inspects a pharmaceutical or biotechnology company’s manufacturing facilities, they can either alert the company ahead of time or show up unannounced. After the inspection is over, the FDA might send what is called an FDA Form 483 or a warning letter. There are differences between each and varying consequences depending on how each of these is handled.

In our recent blog post entitled Prepping for a Successful FDA Inspection, we discussed the importance of having a Site Inspection Readiness Team always “at the ready” for FDA visits, regardless of whether the visits are scheduled or unannounced. But what happens once the inspectors arrive? You should have a checklist on hand for the key logistical considerations.

For pharmaceutical, medical device, and biotech companies, being always “at the ready” for FDA inspections is an absolute necessity. While some inspections are predetermined, others are surprise visits, so it’s critical to have a team and a process in place to ensure you can respond to every inquiry effectively.

In case you’re not familiar with PhUSE, it’s an independent organization that serves as a global platform to discuss topics surrounding programming in the regulated environments of the pharmaceutical and biotechnology industries. And on July 21^st, 2016, PhUSE is hosting a single day event entitled, “Utilizing Risk-Based Monitoring to More Effectively Identify and Mitigate Risk While Ensuring Patient Safety, Data Quality and Integrity” in Deerfield, IL.