Regulatory Archives - SOLABS

All posts tagged “Regulatory”

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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The Right EQMS: The Best Investment You’ll Make This Year

Quality Management - 02.10.2016

By John Carkner, Senior Consultant, SOLABS Quality Assurance & Best Practices Unit Why The Right Enterprise Quality Management System...

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EQMS Implementation & Use in the Clinical Trials Industry: Part 5 – Implementation

Clinical Trials - 12.02.2015

We recently had the opportunity to interview Nathalie Bourgouin, PMP, and Senior Consultant and Project Manager at Skillpad, to gather her...

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In July of this year, the Food and Drug Administration (FDA) issued a Draft Guidance for Industry entitled, Request for Quality Metrics....

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EQMS Implementation & Use in the Clinical Trials Industry: Part 3- Why SOLABS QM is Well-Suited for Clinical Trial Companies

Clinical Trials - 09.30.2015

We recently had the opportunity to interview Nathalie Bourgouin, PMP, and Senior Consultant and Project Manager at Skillpad, to gather her...

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Paper to software clinical trials

EQMS Implementation & Use in the Clinical Trials Industry: Part 2- Moving from Paper to Software

Clinical Trials - 09.23.2015

We recently had the opportunity to interview Nathalie Bourgouin, PMP, and Senior Consultant and Project Manager at Skillpad, to gather her...

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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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EQMS Implementation: Pick the Right Person and System for the Job

Implementation - 07.15.2015

We have all heard the analogy of building a house, and the inherent importance of a good foundation—and how this might apply to the...

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Challenges in Change Control and Automation

Automation - 06.17.2015

I enjoy exchanging ideas with Mr. Graeff and Mr. Prince on quality operations, best practices, and quality management in general. First...

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Supplier Quality Management (SQM) Programs & Enterprise Software Systems

Supplier Quality Management - 03.19.2015

Supply chain security and supplier management are important issues for the global pharmaceutical industry. Over the last few years several...

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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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