Posted on 24. Oct, 2016 by Karl Kapp.
GlaxoSmithKline Plc has proposed the creation of a unit focused on developing vaccines for diseases in markets such as Zika and Ebola that offer little potential for profit but have a large impact on general public health worldwide. Ripley Ballou, Glaxo’s vice president of vaccines, indicated that now is the time for “a radical rethinking [...]
In the last three years alone, FDA has issued 30+ Warning Letters and Form 483 inspectional observations related to electronic records, and many of these are lab-related. The following issues have been found in FDA 483s as they related to data integrity: Data recording – not recording data contemporaneously (at the time of the activity). [...]
Recently, it was announced that Taro, an Israeli based company that manufactures generic over-the-counter ointments, including antibiotic pain relief and Hydrocortisone creams used to relieve itching and minor skin rashes and prescription creams such as Clobetasol, is under investigation. Subpoenas have been issued to Taro Pharmaceutical Industries Ltd and two of its senior officers. The [...]
The Anti-Kickback Statute (AKS) typically overshadows the Stark Law in compliance concerns in the world of healthcare and Life Sciences. That’s understandable for Life Sciences companies since ASK poses the greater compliance risk in the marketing and sale of medical products. Conversely, the Stark Law applies directly to a Life Sciences company’s clients – healthcare [...]
We’ve all heard the old phrase “you learn from your mistakes” but is it just a cute little saying to help you get over a setback or is there substance to the phrase? Well a researcher has looked into the concept of making mistakes and has found that our brains do, indeed, grow when we [...]
Even before the US Sentencing Guidelines and the DOJ/SEC FCPA Guidance enumerated the elements of effective compliance, companies had crafted Codes of Conduct, policies and procedures, training programs and compliance communications tools. Despite these near-universal compliance programs, companies – even those with widely respected compliance programs – have found themselves caught in the crosshairs of [...]
If you want to design instruction that has an impact on learners, you need to follow three steps to ensure success. Tie the instruction to performance objectives. The ultimate question you want to ask yourself when creating instruction is “what do I want the learner to do when the instruction is complete?” What is the [...]
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 [...]