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Compliance Perspectives: September 2012

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Thursday, September 6, 2012. FDA's Response To Globalization Results In Domestic Efficiencies. It’s been widely acknowledged both inside and outside the FDA that increased globalization is putting enormous pressure on the agency and its resources. In 2011, FDA published a Special Report entitled “ Pathway to Global Product Safety and Quality. 8221; which outlined the challenges the agency faces from globalization, and its planned response to those challenges. The report is eye-opening to say the least.

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Compliance Perspectives: June 2012

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Wednesday, June 13, 2012. How Social Media Is Advancing Healthcare. With its recent IPO, Facebook has received a lot of media attention lately. While the news has been mostly financial, the huge sums of money being discussed are not the only numbers that can give pause. Facebook boasts a staggering 900,000,000 users. To put that in perspective, if Facebook were a country, it would be the 3rd largest in the world. And while Facebook is the biggest, it’s not the only social networking giant. Janet Woodcock...

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Compliance Perspectives: July 2012

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Friday, July 27, 2012. What SOPs Do You Need As A Dietary Supplement Distributor? If you look at the cGMP regulations for Dietary Supplements, you’ll notice that only 1 subpart includes the words “holding” or “distributing” in its title. With only 10 or so individual requirements, the aptly-named Subpart M, “ Holding and Distributing,. 8221; is shorter than most. At least 8 of the 16 subparts that comprise 21 CFR Part 111 are applicable to holders and distributors. Do cramped or dark conditions increase ...

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Compliance Perspectives: Is the SDV in Risk-based Monitoring Misunderstood?

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Monday, July 21, 2014. Is the SDV in Risk-based Monitoring Misunderstood? What’s in a name? Not much according to Shakespeare. But the man who penned “A. TransCelerate Defines Source Data Review (SDR). TransCelerate BioPharma (TCB), an industry consortium of 21 large member companies, has outlined a comprehensive approach to risk-based monitoring (RBM), and developed supporting analysis tools and a 5-part training curriculum. In its 2013. Law And Order: SDV. NewSDR newSDV = oldSDV). Here’s the pote...

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Compliance Perspectives: October 2012

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Monday, October 22, 2012. Yes, SOPs Are Hard To Write…It’s Not Just You. Ask anyone who works in a regulated industry about the purpose of SOPs and you’ll be told it has to do with minimizing variation. Consistency, they’ll say, promotes quality. It follows, then, that SOPs must be straight-forward and unambiguous. If procedures are too complex or can be interpreted in a number of ways, they will not produce consistent results, and quality of the end product, whatever it is, will be at risk. SOP writers ...

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Compliance Perspectives: What Does Risk-based Monitoring Mean for QA Auditing?

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Tuesday, December 9, 2014. What Does Risk-based Monitoring Mean for QA Auditing? By now, we all know that risk-based monitoring isn’t just about changing the role of the CRA; it’s transforming the way clinical studies are managed. So what does that mean for QA teams who audit these new processes? Polaris president Celine Clive. Led a roundtable discussion about RBM and its implications for auditing at November’s North Carolina Regulatory Affairs Forum (NCRAF) meeting. We humans are a wonderful lot, a mir...

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Professional Resources1

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North Carolina Regulatory Affairs Forum. Professional development in regulatory affairs since 1992. Become a New Member! Post a Career Opportunity. List a Professional Resource. Trouble with Membership Renewal? Click here to Register. One does NOT need to be a member of NCRAF to list a resource to this page. Listings will generally be posted within 48 hours of submission. All Safe Records Management Solutions Inc. Document Shredding And Imaging Services. Cato Research and Cato Bioventures. Our highly tal...

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Compliance Perspectives: Risk-based Monitoring vs Traditional Monitoring: the ADAMON Project

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Tuesday, November 5, 2013. Risk-based Monitoring vs Traditional Monitoring: the ADAMON Project. I’ve attended has mentioned that government and academic clinical trials commonly employ a RBM strategy. But it’s been quiet. The big headlines necessary to assuage lingering doubts have not been forthcoming. Even as we begin to hear about RBM successes, how will we know if RBM is as good as traditional techniques? And run by the German medical research network TMF. The ADAMON Risk Analysis. Other high-level s...

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Compliance Perspectives: Regulatory Tools Go UFO: Useful, Free & Online

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Tuesday, January 27, 2015. Regulatory Tools Go UFO: Useful, Free and Online. Despite your best efforts, if you’re active in social media, you’ve been drawn into pointless conversations. Indeed, that’s why many people stay away. But if you can tolerate a little noise, I’ve found the fruitful far outweighs the fruitless. Case in point:. LinkedIn Member 1: “This looks like a great resource. I just hope they are planning on adding more countries.”. Who is this sickening optimist? Now you can.”. What proporti...