Data Integrity: Changing Behavior in the Lab

Posted on 20. Oct, 2016 by .

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). [...]

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Generics in the News

Posted on 17. Oct, 2016 by .

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 [...]

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Anti-Kickback Statute and Stark Law

Posted on 13. Oct, 2016 by .

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 [...]

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Mistakes Are Part of Learning

Posted on 10. Oct, 2016 by .

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 [...]

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Does Your Compliance Message Hit Its Mark?

Posted on 07. Oct, 2016 by .

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 [...]

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Three Steps for Designing Meaningful Instruction

Posted on 03. Oct, 2016 by .

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 [...]

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What is a “Pre-Request for Designation?”

Posted on 26. Sep, 2016 by .

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, [...]

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Benefits of Competency Mapping in the GxP Environment

Posted on 21. Sep, 2016 by .

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 [...]

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