Labeling Scrutinized – The Importance of Inspection
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.
Download our watchback ‘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.
Key Learning Objectives:
- Understand the requirements for inspection of printed labels and the consequences of not meeting them.
- Recognize that not all vision inspection solutions deliver the same levels of assurance.
- Find out how to achieve compliance
- Protect reputation & increase patient safety
MEET OUR SPEAKERS
Tony Street, Managing Director & Principal Consultant, Clinlogis
A seasoned industry leader with over 20 years’ experience in the pharmaceutical industry and a career spanning both operational, quality and commercial leadership in Clinical Trial Supplies (IMP) Project Management, GMP Operations, CMC team leadership and IVRS/IRT Project Management. Having held significant roles with GSK, Allergan, Fisher Clinical Services and Parexel and now as Principal Consultant with Clinlogis, Tony brings a unique blend of commercial and operational acumen to any project or organization.
Chris Lentz, VP SaaS Product Management, PRISYM ID
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.
Robert Bowdish, VP Clinical Trials Business Development, PRISYM ID
Robert Bowdish is PRISYM ID’s Vice President Clinical Trials Business Development 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.