October 2017 Posts

CDER Metrics Don’t Have to be Frightening

CDER Metrics Don’t Have to be Frightening

Cynthia Lambert, Regulatory Specialist, Pilgrim Quality Solutions

The FDA’s CDER Metrics program is set to launch early next year. Although this initiative is voluntary in 2018, it signals a new direction for how the FDA will approach future compliance and inspection practices. A risk-based, data-driven approach will become key to ongoing compliance and success. It’s important to understand and prepare for the upcoming CDER Metrics initiative even if you’re not yet ready to participate.
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ISO 13485:2016 Audit Readiness: Your Questions Answered

ISO 13485:2016 Audit Readiness: Your Questions Answered

Kari Miller, Regulatory & Product Management Leader, Pilgrim Quality Solutions
Cynthia Lambert, Regulatory Specialist, Pilgrim Quality Solutions

Last week, Pilgrim hosted a webinar titled “The Ultimate Guide to ISO 13485:2016 Assessment Readiness.” During the session, we presented comprehensive tips, best practices, and solutions to ensure that your team is prepared and confident when the assessor arrives. If you weren’t able to attend the live webinar, you can access the on-demand version here.

ISO 13485:2016 is a critical topic for medical device manufacturers, and we were delighted to address many questions on assessment readiness at the end of the presentation. Here are 5 interesting questions (with answers) from the webinar’s Q&A session that will help you better prepare for your assessment.
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Make the Move: Solutions for Next-Generation QMS

Make the Move: Solutions for Next-Generation QMS

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

More than ever before, Life Science quality professionals are feeling the pressure of increasing regulations and the rapid pace of business and industry-driven change. In previous posts, we’ve discussed these challenges, as well as the imperatives for the next generation of quality solutions that will help meet them. Next-generation enterprise quality management systems (QMS) must drive real product quality, link closely with business objectives, enable global harmonization, support enterprise quality, and enable an organization’s culture of quality. That’s a tall order for most quality systems that are deployed within Life Sciences organizations today.
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