June 2017 Posts

Strategic Approaches in Integrating Quality and Risk Management

Strategic Approaches in Integrating Quality and Risk Management

Florian Czaszewicz, Industry Solutions Consultant, Pilgrim Quality Solutions

Recently, I had the opportunity to present a webinar with Thermo-Fisher Scientific, E.M.M.A. International Consulting, and The Knowledge Group addressing Strategic Approaches to Integrating Risk and Quality Management within the Life Sciences. We examined the broad subject of risk, first using a telescope, and then more closely with a spyglass, to provide both macro and micro views of quality and risk management.
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ISO 13485:2016 and Supplier Management – A Reflection of the World Around Us

ISO 13485:2016 and Supplier Management – A Reflection of the World Around Us

Kari Miller, Vice President of Regulatory and Product Management, Pilgrim Quality Solutions

The global economy is often the topic of blogs, articles, and macroeconomic discussions. It’s no surprise that it’s become a leading consideration in the field of Quality as well. The global economy has added complexity to our supply chains making it more important than ever to assess and control supplier risk. Lengthy supply chains make it more difficult than ever to manage suppliers and remain compliant with the plethora of regulatory requirements around the world. The updates to ISO 13485:2016 reflect this reality.
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EU-U.S. Privacy Shield Compliance: Get on Board

EU-U.S. Privacy Shield Compliance: Get on Board

Tom Colgan, Director of Cyber Security, Pilgrim Quality Solutions

As we come up on the first year anniversary of EU commission adoption of EU-U.S. Privacy Shield framework, I wanted to take a few minutes to discuss Privacy Shield and its evolution. EU member states approved EU-U.S. Privacy Shield on July 8, 2016, followed by EU Commission adoption on July 12, 2016. The U.S. Department of Commerce started taking applications for EU-U.S. Privacy Shield on August 1, 2016. Since that time, over 2,000 business entities have submitted the proper registration requirements and been approved as EU-U.S. Privacy Shield certified per the published list on the Privacy Shield website.
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Global Harmonization and the Link between ISO 13485:2016 and MDSAP

Global Harmonization and the Link between ISO 13485:2016 and MDSAP

Kari Miller, Vice President of Regulatory & Product Management, Pilgrim Quality Solutions

Let’s face it. The world of trade is shrinking. It’s no longer enough to design, build, and distribute a product in compliance with the manufacturer’s national regulations. Within each phase of product development, the manufacturer must abide by global regulations as well. If you’re a medical device manufacturer, and you haven’t started looking at ISO 13485:2016 and the Medical Device Single Audit Program (MDSAP), you’re running out of time!
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Pick Up a New Habit: Making Quality a Priority

Pick Up a New Habit: Making Quality a Priority

Sandy Carson, Marketing Communications & Events Manager, Pilgrim Quality Solutions

“Quality isn’t an act, it’s a habit.”

Aristotle said it first. But it doesn’t take a philosopher or a scientist to recognize that excellence doesn’t happen overnight. Just ask the drum major in the local high school band or the prima ballerina in the regional ballet company. It takes ongoing commitment to reach the pinnacle and continuous improvement to remain there.

The QA director at a leading pharma or medical device company know this, too. Very well. The practice of continual improvement starts with a unified, enterprise-wide commitment to ongoing best efforts and to process improvement. (more…)