Pharma IQ Members

Quality Management
22 results
of 2
Posted: 19/06/2017
MT 5
QP, QC and laboratory managers are liable for lost data. Unknown to many lab professionals, a standalone system with electronic records is problematic. These systems can risk a laboratory being issued an FDA warning letter and incurring extremely high costs.

Download this whitepaper to learn about the dangerous misconceptions in the pharma industry about 21 CFR Part 11 compliant instruments. Full Content »
Contributor: Chanice Henry
Posted: 21/06/2016
Chan
The transition from paper to electronic Trial Master File (TMF) system, is a significant task, which is further complicated with the varying views and opinions complicating the route to standardisation. This is partially solved by the new directives under construction alongside the EMA’s updated information providing giving insight into inspector’s reviewing behaviours and what has been examined as of late for eTMFs. These much needed points of clarification help inform pharma and biotech companies on how to best create and maintain an eTMF system. Full Content »
Contributor: Pharma IQ
Posted: 31/05/2016
Pharma IQ
Ahead of the 2016 Lab Informatics Summit, Pharma IQ discussed the subject of data knowledge management with lab informatics and more specifically manufacturing with a selection of experts. Full Content »
Contributor: Tony Hitchcock
Posted: 10/05/2016
Tony Hitchcock
Earlier this year I was fortunate enough to attend the Disposable Solutions meeting in Munich. A common theme of discussions was the on-going debates around the issues of leachable and extractables and the associated testing standards. This is a topic that has been debated for as long as I have been attending meetings on single use systems, and still seems to be a long way from a consensus between various end users and manufacturing bodies on how to address this issue. Full Content »
Contributor: Pharma IQ
Posted: 05/05/2016
Pharma IQ
According to recent research, the global pharmaceutical packaging market is forecasted to reach more than US$80 billion in revenue by 2020.

This expanding market is advancing towards optimization in regards to effectiveness. However, as noted in recent research, this wasn’t always the case: “Packaging was considered as an afterthought which was required merely in the final stages of manufacturing for many pharmaceutical companies about a decade ago. But of late, pharmaceutical packaging has quickly become an essential part of the drug delivery system..” (1) Full Content »
Contributor: Videojet Technologies Ltd.
Posted: 31/03/2016
Video Jet
Implementation deadlines are looming large, leaving an urgent need for both pharmaceutical and medical device manufacturers to find and implement solutions to stay compliant. With only a few years left to comply with pack level serialization in the US and Europe, the time to complete the changes to existing or new production and packaging lines is rapidly running out. Full Content »
Contributor: Chanice Henry
Posted: 28/04/2016
Chan
While the US advances with its coverage of medical device classes within the U.S. Food and Drug Administration (FDA) Unique Device Identification regime, other countries around the globe are progressing their own track and trace strategies for medical devices. Through the collaboration of the world’s regulatory agencies it is hoped that a synchronized approach to medical device identification will be achieved on an international level, amidst their efforts to tackle counterfeiting, increase accountability and enable safety corrective measures. (2) Full Content »
Contributor: Kate Torchilin Ph.D.
Posted: 28/04/2016
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Biomarkers are an essential part of such a translational effort and are critical to understanding human disease. Human biospecimens can provide a bridge between the early discovery and molecular mechanism of the disease and the clinical utility. Commonly, human biospecimens are used to: Full Content »
Contributor: Miss Chanice Henry
Posted: 12/04/2016
Miss Chanice Henry
The first quarter of 2016 hosted plenty of activity from the pharma and cold chain industries. This was seen in the form of patent challenges, landmark agreements, extreme market reactions as well as a nationwide medicine ban for hundreds of products. Read on for this quarter’s highlights from Pharma IQ Full Content »
Contributor: Andrew Love
Posted: 08/04/2016
Andrew Love
In this and subsequent articles, Andrew will outline a series of tips, based on experience he has gained working on multiple serialisation programmes, to help develop and implement your serialisation strategy. Full Content »
Contributor: Chanice Henry
Posted: 05/04/2016
Miss Chanice Henry
Pharma IQ zooms through the latest predicted trends for the compound and biological sample management industries. The video explores investment levels, team sizes, top challenges and areas for growth. Full Content »
22 results
of 2
Contributor: Chanice Henry
Posted: 05/04/2016
Miss Chanice Henry
Pharma IQ zooms through the latest predicted trends for the compound and biological sample management industries. The video explores investment levels, team sizes, top challenges and areas for growth. Full Video »
Contributor: Pharma IQ
Posted: 04/10/2010
In this interview Jos van den Heuvel, Director of External Manufacturing at Janssen Pharmaceutica NV, Johnson & Johnson, speaks to Rebecca Maschke from Pharma IQ, about supplier integration and the advantages of establishing a data network collaboration. Full Podcast »
Contributor: Jon Wetzel
Posted: 31/08/2011
Jon Wetzel
From a high level perspective a Quality Management System (QMS) is great but to the lab workers it’s more like a pile of “red tape” that stops them from doing or improving their work. Here’s what you can do to put the “Quality” back into your QMS. Full Column »
Posted: 19/06/2017
MT 5
QP, QC and laboratory managers are liable for lost data. Unknown to many lab professionals, a standalone system with electronic records is problematic. These systems can risk a laboratory being issued an FDA warning letter and incurring extremely high costs.

Download this whitepaper to learn about the dangerous misconceptions in the pharma industry about 21 CFR Part 11 compliant instruments. Full Whitepaper »