John Carkner Archives - SOLABS

All posts tagged “John Carkner”

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...

Read more → Comments Off on Top 10 Quality & Best Practices Blogs of the Last Year
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...

Read more → Comments Off on Lean Manufacturing and Quality
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...

Read more → Comments Off on Issue Escalation: 5 Tips for Communicating with Senior Management
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...

Read more → Comments Off on Quality and Safety Have A Lot in Common
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...

Read more → Comments Off on FDA Contract Manufacturing Guidance and EQMS
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...

Read more → Comments Off on Product Documentation: Essential to an Effective Quality Program
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...

Read more → Comments Off on Creating & Sustaining a Quality Culture: Part 3 – Internal & External Messaging
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...

Read more → Comments Off on Creating & Sustaining a Quality Culture: Part 2 – Making an Impact
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...

Read more → Comments Off on Creating & Sustaining a Quality Culture: Part 1 – Living the Values
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...

Read more → Comments Off on Creating & Sustaining a Quality Culture: Introduction
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...

Read more → Comments Off on 5 Tips for Communicating with Auditors
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...

Read more → Comments Off on Preparing for an Audit

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...

Read more → Comments Off on The Right EQMS: The Best Investment You’ll Make This Year