Brian Graeff Archives - SOLABS

All posts tagged “Brian Graeff”

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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Pharma, Medical Device, Biotech Quality Manangement System Selection Guide

EQMS Software Evaluation & Selection Guide for the Life Sciences

EQMS - 02.03.2016

The EQMS Software Evaluation and Selection Guide has been designed by the SOLABS Quality & Best Practices Unit expressly to provide...

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In July of this year, the Food and Drug Administration (FDA) issued a Draft Guidance for Industry entitled, Request for Quality Metrics....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

Corrective Action & Preventive Action (CAPA) Effectiveness Checks

Corrective & Preventive Action - 08.12.2015

The need for periodic performance and effectiveness checks should be agreed upon and documented as part of a compliant Corrective Action &...

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EQMS Integration and Interfaces: GxP Activities, ERP & LIMS Systems

EQMS - 07.29.2015

Many companies are seeking a level of integration between enterprise software solutions of various types—to the extent that all of these...

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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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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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Cost of Quality

Quality Management - 01.28.2015

Proper Quality management can be a strategic advantage to a pharmaceutical, bio-technology or medical device manufacturing company. There...

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