LABELING SCRUTINIZED – THE IMPORTANCE OF INSPECTION

Affordable Networking & Training
10/13/2020
Online

In life sciences, labelling is what it’s all about. Whether you are a discovery scientist deep in the lab or elbows deep in clinical trials, whatever you are doing day to day is ALL about the label. Most of us in the wide expanse of life sciences R&D operations don’t do labelling on a day to day basis, but to the extent that we work for a business that needs to make money, and the money a sponsor makes is determined by the label, the more we know about labelling, the better. Here is some free “training” on labelling. This is just a small slice, and it is being presented by a vendor that wants to sell something, also this may raise more questions than answers, but if you’re an independent consultant and as such constantly stretching your knowledge horizons for the benefit of your practice and your customers, you may benefit from dropping in!

WHY DATA LEVEL INSPECTION IS VITAL TO YOUR LABELING PROCESS

Label inspection (whether for Medical Device or Clinical Trials) is mandatory, but how organizations go about this task is more discretionary. Label inspection can be completed manually or by machine, however the accuracy of either of these routes needs to be assured. But what does this mean, how accurate can an individual or machine be, and what is the real solution?

Organizations must be certain that both their labels are of a high print quality (e.g. clarity of what is printed) and that the data printed from their labeling software is correct. This sounds simple in theory, but in practice it is not.

For Medical Device manufacturers, failing to meet regulatory compliance could lead to your product being out of specification, risking penalties, rework and even product recalls. A wrongly labeled product being used by a health professional could result in serious complications for a patient.

For Clinical Research Organizations, incorrect labeling could invalidate trial protocols, severely impacting research and clinical trials programs.

Join us for this information packed webinar on Tuesday 13th October at 9am EST/2pm GMT/3pm CET on ‘Labeling Scrutinized – The Importance of Inspection’ to better understand how to improve the quality of labels, avoid risk of recalls, ensure auditability, protect reputation and increase patient safety.

Presented by

Chris Lentz ,

VP SaaS Product Management

Chris Lentz has been working at PRISYM ID for over 5 years, focusing on product management of PRISYM’s SaaS and Vision Inspection solutions.
With over 25 years’ experience in deploying and supporting enterprise software solutions across many sectors, Chris has spent the last several years bringing to market SaaS offerings that enable organizations to access high quality services based on leading software technologies.
[Chris holds an MSc in Computing for Commerce and Industry.]

Robert Bowdish ,

Director, Clinical Trials Sales

Robert Bowdish is PRISYM ID’s Director of Clinical Trials Sales for North America. He has wide-ranging healthcare industry experience, having started as a pharmaceutical sales representative 26 years ago. Joining from Parexel Informatics, and previously working with Takeda Pharmaceuticals, he has a specialization in the regulatory and clinical software solutions and services market. Robert helps clients understand how PRISYM ID products provide value integrated into a clinical trial supply chain to deliver regulated content and labeling.

 

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