FDA Archives - SOLABS

All posts tagged “FDA”

Out of the box Quality Management System (QMS) Save Money

Out of the Box: A Path to Success

Quality Management - 07.19.2017

This is the third blog in a series about the expression “Out of the Box” and how it relates to the Life Sciences industry. In the...

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Buying out of the box sofware: Biotech, pharma, medical devices

Buying Out of the Box Software

Quality Management - 07.12.2017

In this blog, I will discuss the benefits of buying out of the box software. In my previous blog in this series, I discussed thinking out...

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Thinking Out of the Box in the Life Science

Thinking Out of the Box in the Life Sciences

Quality Management - 07.05.2017

Out of the box is a much-used expression but with a couple of completely different meanings! In this blog, I will discuss thinking out...

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Head of SOLABS' Quality & Best Practices Unit - Tips for Communicating with FDA, EMA or Health Canada Auditors

Top 10 Quality & Best Practices Blogs of the Last Year

Quality Management - 06.16.2017

At SOLABS, we're lucky enough to have Brian Graeff (former VP of Quality Operations at Sunovion Pharmaceuticals Inc.) and John Carkner...

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Lean Manufacturing: Efficiency in Pharma, Biotech, Medical Devices

Lean Manufacturing and Quality

Lean Manufacturing - 05.31.2017

Lean manufacturing has been defined as the systematic elimination of waste in manufacturing systems. While I am certainly not an expert on...

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Communicating an Issue with Sr. Management at Life Sciences Companies

Issue Escalation: 5 Tips for Communicating with Senior Management

Quality Management - 04.26.2017

A trait that many leaders in the life sciences share is that they don’t like surprises. Perhaps they don’t mind pleasant surprises, but...

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Quality Manufacturing Safety in Pharma & Biotech

Quality and Safety Have A Lot in Common

Quality Management - 03.22.2017

Aside from the obvious moral obligation, most organizations in the Life Sciences industry invest in safety programs for very sound business...

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Food & Drug Administration Contract Manufacturing Pharma Guidance

FDA Contract Manufacturing Guidance and EQMS

Quality Management - 02.01.2017

Recently published guidance from the FDA (Contract Manufacturing Arrangements for Drugs: Quality Agreements, November 2016) outlines their...

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Production of pharmaceutical product documentation

Product Documentation: Essential to an Effective Quality Program

Quality Management - 01.04.2017

Provenance – Not Just for Fine Art! The term “provenance” is used in the art world in reference to the evidence that supports the...

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Quality Culture: Internal & external messaging

Creating & Sustaining a Quality Culture: Part 3 – Internal & External Messaging

Quality Management - 11.09.2016

By John Carkner, Senior Consultant, SOLABS Quality Assurance & Best Practices Unit In previous discussion, we've looked at the...

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Quality Culture for Pharma, Biotech, Medical Device and R&D

Creating & Sustaining a Quality Culture: Part 2 – Making an Impact

Quality Management - 10.26.2016

By John Carkner, Senior Consultant, SOLABS Quality Assurance & Best Practices Unit There are many ways that we can reinforce the quality...

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Life Sciences Quality Culture on Target

Creating & Sustaining a Quality Culture: Part 1 – Living the Values

Quality Management - 10.05.2016

By John Carkner, Senior Consultant, SOLABS Quality Assurance & Best Practices Unit There are two important elements to effective...

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Creating a Quality Culture in Pharma, Biotech and Clinical Trials Companies

Creating & Sustaining a Quality Culture: Introduction

Quality Management - 09.21.2016

By John Carkner, Senior Consultant, SOLABS Quality Assurance & Best Practices Unit In July 2015, the U.S. Food & Drug Administration...

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Head of SOLABS' Quality & Best Practices Unit - Tips for Communicating with FDA, EMA or Health Canada Auditors

5 Tips for Communicating with Auditors

Audits - 09.07.2016

By John Carkner, Senior Consultant, SOLABS Quality Assurance & Best Practices Unit The best organizations look at audits as an...

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Preparing for an FDA Audit

Preparing for an Audit

Audits - 08.24.2016

By John Carkner, Senior Consultant, SOLABS Quality Assurance & Best Practices Unit Some people might consider a Quality audit of their...

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Head of SOLABS' Quality & Best Practices Unit - Tips for Communicating with FDA, EMA or Health Canada Auditors

Handling Customer Product Complaints

Complaints - 07.13.2016

By Brian Graeff, Head of the Quality & Best Practices Unit, SOLABS The quality process for handling customer complaints is unique in...

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Corrective & Preventive Action (CAPA) Bridges

Does Your CAPA Process Need a CAPA?

Corrective & Preventive Action - 04.27.2016

By Brian Graeff, Head of the Quality Best Practices Unit, SOLABS I have had the opportunity and privilege to work in the pharmaceutical...

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Periodic Reviews Controlled Documents

Document Control & Change Control: Periodic Reviews & Retraining

Document Control - 03.16.2016

By Philippe Gaudreau, Founder & CEO of SOLABS Our previous blog in the Document Control Series covered the various and incremental...

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FDA Quality Metrics

Intro to FDA’s Request for Quality Metrics

Industry News - 11.04.2015

In July of this year, the Food and Drug Administration (FDA) issued a Draft Guidance for Industry entitled, Request for Quality Metrics....

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Value: License to Operate Pharma, Biotech, Med Devices

What Is My License to Operate (LTO) Worth?

Quality Management - 08.26.2015

The Life Sciences industry has a history of heavy regulation. Whether your company markets pharmaceutical, biotechnology or medical device...

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