How are Quality & Compliance Teams Progressing Along the Quality-Based Learning Maturity Model

Posted on 15. Apr, 2014 by .

When we conducted our annual benchmarking study with clients in 2013, we learned just how far clients have advanced along the “Quality-based Learning Maturity Model” – I wanted to explain this model in a bit more detail, as it’s stirring some interesting discussions with clients who benefit from our learning management system, as well as [...]

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FCA 2013 Patterns Set 2014 Trends

False Claims Act: 2013 Patterns Set 2014 Trends

Posted on 11. Apr, 2014 by .

For Health Care companies, Fiscal Year 2013 was a year of record-setting fines and settlements under the False Claims Act. According to the US Department of Justice (DOJ), the government recovered $3.8 billion under the Act, leading the Assistant Attorney General for DOJ’s Civil Division to describe 2013 as a “banner year for civil fraud [...]

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Risk Management: How to Train Employees Successfully

Posted on 28. Mar, 2014 by .

One of the most challenging and difficult issues Life Science companies face is assessing risk throughout the product lifecycle.  FDA expects companies to assess the risk to users, patients, and the environment. Regulatory agencies recognize the ISO 14971 standard as a benchmark for medical devices and the ICH Q9 guidance for pharmaceuticals/biologics as standards to [...]

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The Goal: Zero Recalls, Zero Observations and Zero Warning Letters

Posted on 25. Mar, 2014 by .

A leading manufacturer of medical devices and supplies, diagnostic imaging agents and pharmaceuticals, had a plan: they were faced with a challenge: they needed to put into place a quick, easily accessible way to share and discuss quality events, ideas and initiatives across the entire organization. To meet its aggressive business, quality and compliance goals [...]

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What BIMO Inspections Reveal

Posted on 05. Mar, 2014 by .

The US Food and Drug Administration’s (FDA) Bioresearch Monitoring Program (BIMO) has a three-pronged mission: To protect the rights, safety and welfare of subjects in FDA-regulated trials; To determine the accuracy and reliability of clinical trial data submitted to the FDA in support of research or marketing applications for new products; To assess compliance with [...]

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Ethical Guidelines for Sales & Marketing

Posted on 28. Feb, 2014 by .

Medical Device and Diagnostic companies face particular compliance risks in the marketing, sale or delivery of their products to end users. Those risks don’t disappear – in fact, they may even escalate – when a company uses third party sales and marketing intermediaries to assist in the marketing, sale or distribution of its products. AdvaMed [...]

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Effective Third Party Sales and Marketing Compliance

Posted on 24. Feb, 2014 by .

When building a compliance program for third party agents and distributors, what are the most significant risks to consider? That was the key issue discussed during a February 12th UL EduNeering webinar, Elements of an Effective Third Party Sales and Marketing Compliance Program, featuring Denise Pedulla and Peter Katz from Berkeley Research Group (BRG). BRG [...]

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Transforming Clinical Trials

Posted on 19. Feb, 2014 by .

Sponsors and CROs, monitors and clinical personnel agree that consistent, high-quality learning, communication and management systems are essential to protecting participants in clinical trials while accelerating patient access to innovative, effective new drug therapies. Despite that common recognition, clinicians have grappled with unresponsive systems that lacked the education and communication tools to ensure human subject [...]

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