Tampa, FL – Oct. 17, 2014 – Tampa-based Pilgrim Quality Solutions, a leading global provider of enterprise quality management software and services for the Life Sciences, is co-sponsoring FDAnews’ autumn 2014 conferences, including the 9th Annual FDA Inspections Summit, the Medical Device Risk Management conference, and the conference on Conducting Advanced Root Cause Analysis and CAPA Investigations.
The 9th Annual FDA Inspections Summit, taking place October 22-24, 2014 at the Doubletree Bethesda Hotel in Bethesda, MD, will be an unprecedented gathering of the nation's most influential and innovative thought leaders in quality, compliance and inspectional readiness. The lineup of presenters will include top officials from CDER, CDRH, CBER, the Office of Regulatory Affairs and other outstanding industry leaders who will discuss debate and uncover the latest priorities, expectations and best practices.
Topics this year will include a look at FDA’s Quality Metrics initiative, the latest FDA reorganizations, a day in the life of an investigator, best practices in FDA 483 and warning letter management and recovery. Two pre-conference workshops will focus on drugs and device.
“Pilgrim has firmly established itself not only as a leading provider of enterprise quality management software, but a thought leader and educator within the Life Sciences,” said Thierry Durand, President & Chief Executive Officer of Pilgrim Quality Solutions. “In sponsoring these webinars, we’re giving the conference speakers a platform to share best practices based on their experiences, so attendees can learn to make continuous improvements to gain a competitive advantage.”
FDAnews’ Medical Device Risk Management: From Understanding to Applications, Nov. 5-6, 2014, at the Chicago Marriott, in Schaumburg, IL, will examine the widely accepted standard for product risk management: Failure Modes and Effects Analysis (FMEA).With the FDA and international regulatory bodies ramping up risk management requirements for medical devices, is FMEA enough? Experts say no, so attendees will learn about additional methods of risk preparedness and unique tools to evaluate how they’re working for your organizations.
The third conference sponsored by Pilgrim, Conducting Advanced Root Cause Analysis and CAPA Investigations, will be held at the Tampa Marriott Waterside Hotel & Marina, Nov. 5-6, 2014. Attendees will learn how to respond to the FDA and implement effective CAPAs to prevent regulatory action and get a closeout letter. They also will get an insider’s view of the FDA's own training program for investigators, and discuss lessons learned from nine years of FDA warning letter citations on CAPA investigations.
For more information these and other FDAnews conference, visit www.fdanews.com/events.
About Pilgrim Quality Solutions Pilgrim Quality Solutions is a leading global provider of enterprise quality management software and services for the Life Sciences and other highly regulated industries. For more than 20 years, our solutions have automated thousands of processes that ensure the quality of life’s most important products. Product quality and patient safety increase while risks decline. Our on-premise and cloud technologies reflect quality industry standards and include electronic signatures, audit trails and validation packs - helping customers more easily achieve compliance and pass regulatory audits. With Pilgrim Quality Solutions as your partner, you are prepared to succeed. For more information, visit www.pilgrimquality.com
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The 9th Annual FDA Inspections Summit, taking place October 22-24, 2014 at the Doubletree Bethesda Hotel in Bethesda, MD, will be an unprecedented gathering of the nation's most influential and innovative thought leaders in quality, compliance and inspectional readiness. The lineup of presenters will include top officials from CDER, CDRH, CBER, the Office of Regulatory Affairs and other outstanding industry leaders who will discuss debate and uncover the latest priorities, expectations and best practices.
Topics this year will include a look at FDA’s Quality Metrics initiative, the latest FDA reorganizations, a day in the life of an investigator, best practices in FDA 483 and warning letter management and recovery. Two pre-conference workshops will focus on drugs and device.
“Pilgrim has firmly established itself not only as a leading provider of enterprise quality management software, but a thought leader and educator within the Life Sciences,” said Thierry Durand, President & Chief Executive Officer of Pilgrim Quality Solutions. “In sponsoring these webinars, we’re giving the conference speakers a platform to share best practices based on their experiences, so attendees can learn to make continuous improvements to gain a competitive advantage.”
FDAnews’ Medical Device Risk Management: From Understanding to Applications, Nov. 5-6, 2014, at the Chicago Marriott, in Schaumburg, IL, will examine the widely accepted standard for product risk management: Failure Modes and Effects Analysis (FMEA).With the FDA and international regulatory bodies ramping up risk management requirements for medical devices, is FMEA enough? Experts say no, so attendees will learn about additional methods of risk preparedness and unique tools to evaluate how they’re working for your organizations.
The third conference sponsored by Pilgrim, Conducting Advanced Root Cause Analysis and CAPA Investigations, will be held at the Tampa Marriott Waterside Hotel & Marina, Nov. 5-6, 2014. Attendees will learn how to respond to the FDA and implement effective CAPAs to prevent regulatory action and get a closeout letter. They also will get an insider’s view of the FDA's own training program for investigators, and discuss lessons learned from nine years of FDA warning letter citations on CAPA investigations.
For more information these and other FDAnews conference, visit www.fdanews.com/events.
About Pilgrim Quality Solutions Pilgrim Quality Solutions is a leading global provider of enterprise quality management software and services for the Life Sciences and other highly regulated industries. For more than 20 years, our solutions have automated thousands of processes that ensure the quality of life’s most important products. Product quality and patient safety increase while risks decline. Our on-premise and cloud technologies reflect quality industry standards and include electronic signatures, audit trails and validation packs - helping customers more easily achieve compliance and pass regulatory audits. With Pilgrim Quality Solutions as your partner, you are prepared to succeed. For more information, visit www.pilgrimquality.com
Help employers find you! Check out all the jobs and post your resume.
