FDA Archives - SOLABS

All posts tagged “FDA”

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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Introduction to FDA’s Request for Quality Metrics: Guidance for Industry (Released July 2015)

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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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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Audit Trails: Patterns and Part 11 Compliance

Audits - 04.22.2014

The requirement for audit trails has not come about with the evolution of electronic systems. The ability to audit multiple sorts of...

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