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Pilgrim Quality Solutions
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Today 8:30AM–5:30PM
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#MDSAP audits are coming soon. This study guide from #FDA #CDRH outlines the single audit model and audit sequence. http://tinyurl.com/z4kf2zq
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A #Quality Management System (#QMS) needs to be enterprise strong as the value chain expands to include more suppliers and regulators. http://hubs.ly/H05TwJC0
Kari Miller, Vice President of Regulatory & Product Management, Pilgrim Quality Solutions Let’s face it, the arms of regulators are getting longer and so is their vision. The extended supply chain is experiencing additional oversight by...
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Go right to the source to stay up-to-date on #MDSAP. Get the latest updates and subscribe for more from the #FDA. http://hubs.ly/H05SxX60


The International Medical Device Regulators Forum (IMDRF) · disclaimer icon recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. At its inaugural meeting in Singapore in 2012, the IMDRF ...
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A single audit program means that #FDA will accept #MDSAP results in place of a routine inspection. Learn more here: 
MDSAP AU P0019.003: Medical Device Regulatory Audit Reports Policy (PDF - 529KB) · MDSAP AU F0019.1.005 Medical Device Regulatory Audit Report (PDF - 1MB) This file must be used with Adobe Acrobat or Adobe Reader, version 10.0 or greater. Other readers may corrupt the file which contain ...
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Have you set your quality and compliance goals and resolutions for 2017? Pilgrim’s quality and compliance experts help you start the new year off right. http://hubs.ly/H05PzZS0
A new year has begun. For most of us that means a fresh start and a brand new set of goals. But have you set your quality and compliance goals and resolutions for 2017? Whether you’re just getting started or planning the next steps in your...
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Focused on #MDSAP, #ISO13485, #GMP? Download our audit-readiness Ebook to prep for audits, inspections, and success.


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MDSAP Fact: #FDA for cause or follow-up inspections will not be affected by the Medical Device Single Audit Program. http://hubs.ly/H05WlCS0


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George Penton has joined #Pilgrim #Quality Solutions as Vice President of Global Services. http://hubs.ly/H05VHyl0
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Questions about #MDSAP? Get answers from the #FDA with this detailed question and answer document. http://tinyurl.com/gs6wxqr
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Pilgrim’s VP of Regulatory & Product Management and its VP of QA & Validation will address attendees at the 5th Annual Medical Device Safety Monitoring & Reporting Conference Jan. 25-26 in Las Vegas. http://hubs.ly/H05QT090
that Kari Miller, Pilgrim’s Vice President of Regulatory & Product Management, and Konyika Nealy, Vice President of QA & Validation, will address attendees at the 5th Annual Medical Device Safety Monitoring and Reporting conference, being held January 25-26, 2017, in Las Vegas.
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Looking for resources on #MDSAP? Link to guidance documents, watch a webinar and learn how to apply at: http://hubs.ly/H05MVMb0


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FDA says device manufacturers in #MDSAP pilot are committed to #QMS for product quality and regulatory compliance. http://tinyurl.com/gs6wxqr

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Contact Information
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2807 W Busch Blvd Tampa, FL 33618
2807 West Busch BoulevardUSFloridaTampa33618
(813) 915-1663pilgrimquality.com
Corporate OfficeToday 8:30AM–5:30PM
Tuesday 8:30AM–5:30PMWednesday 8:30AM–5:30PMThursday 8:30AM–5:30PMFriday 8:30AM–5:30PMSaturday ClosedSunday ClosedMonday 8:30AM–5:30PM
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Neil Pirelli's profile photo
Neil Pirelli
4 months ago
Poor software and support
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Eric Molina
2 weeks ago