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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 (former President and CEO at Pillar5 Pharma Inc.) on our team. Every month Brian and John publish a Quality & Best Practices article to give you their insights into how best to manage common challenges...

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 lean implementation, I have seen firsthand the tangible benefits of the application of lean thinking to quality processes. Aspects of waste addressed by lean principles include:...

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 generally, they want to hear about issues promptly. While there are often formal notification requirements for quality issues, there are also sound business reasons for informing the leadership...

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 reasons: Employees are an organization’s most valuable resource, and ensuring their safety also safegaurds the organization’s value Similarly, while there is an ethical duty to produce...

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 expectations and suggestions around contract manufacturing relationships and Quality Agreements. In the simplest summary of this guidance, it suggests that the product owner and the contractor are...

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 authenticity of a work of art. It is what differentiates a valuable classic painting from a clever copy. In the production of pharmaceutical products, I like to think of the documentation that...

SOLABS Customer Support & Software Product Release

Q&A with SOLABS’ Product Release Manager

EQMS - 12.07.2016

By Martha Bailey, Product Release Manager, SOLABS As part of our monthly SOLABS technology blog series, we’re speaking with our developers and analysts on their reflections on the industry, its development and rapid changes, and how their area of current focus may be pertinent to compliance/regulatory and the future of Enterprise...

Product Specialist Role

EQMS - 11.22.2016

By Daniel Cadoch, Product Specialist, SOLABS The Product Specialist role is a multi-faceted one within any organization, let alone an already-specialized software company. Product Specialists are both technical (in that they are tasked with knowing their product inside and out), as well as sales-oriented. The role is, in essence, the...

Optimizing SOLABS Quality Management System for the Life Sciences

Optimizing SOLABS QM Core Software Performance

EQMS - 11.16.2016

By David Abran-Côté, Software Developer, SOLABS As part of our monthly SOLABS technology blog series, we’re speaking with our developers and analysts on their reflections on the industry, its development and rapid changes, and how their area of current focus may be pertinent to compliance/regulatory and the future of Enterprise...

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 importance of demonstrating the quality commitment of the organization in our day-to-day actions, and various ways to create an impactful quality message. To conclude this topic, I’d like to discuss ways to...

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 culture of an organization. To illustrate this point, I’d like to share an example from my career: During a visit from a major customer, I was accompanying a tour of the manufacturing facility....

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 communication in the workplace: the content to be communicated, and the demonstration of that content. If a policy change is communicated, then leaders of the organization, both managers and the informal...

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 (FDA) published the Draft Guidance for Industry entitled, Request for Quality Metrics, requesting public comment on whether to give establishments the opportunity to submit additional, optional metrics...

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 opportunity to showcase their operations, and recognize that good audits are invaluable in emphasizing the importance of compliance to management and staff. A crucial aspect in relating to auditors is sticking...

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 facility as an aggravating ordeal--a time to grit one’s teeth and suffer through endless questioning and review. The best organizations, however, view good audits as an opportunity to both showcase...

SOLABS Quality Business Processes- Audits, CAPA, Change Control, Investigations

QM APPS: Quality Business Processes & Report Configuration

Quality Business Processes - 07.27.2016

By Francis Lau, System Analyst, SOLABS As part of our monthly SOLABS technology blog series, we’re speaking with our developers and analysts on their reflections on the industry, its development and rapid changes, and how their area of current focus may be pertinent to compliance/regulatory and the future of Enterprise Quality...

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 many ways. First, it is the only quality process that interacts directly with the customer. Company representatives frequently communicate directly with pharmacists, nurses, doctors or the patients to...

Reports & Metrics in Life Sciences

How Optimizing Access to Reports & Detailed Metrics Maximizes ROI

Reports & Metrics - 06.29.2016

By Anne-Marie Pinet, System Analyst, SOLABS As part of our monthly SOLABS technology blog series, we’re speaking with our developers and analysts on their reflections on the industry, its development and rapid changes, and how their area of current focus may be pertinent to compliance/regulatory and the future of Enterprise Quality...

SOLABS Quality Business Processes- Audits, CAPA, Change Control, Investigations

QM APPS Business Process Engine

Quality Business Processes - 06.15.2016

By Diem Le, QM APPS Lead Developer, SOLABS For the second instalment of this two-part interview, we’re talking with SOLABS QM APPS Lead Developer Diem Le, whose current work finds her collaborating closely with a Development team engineering QM APPS, the powerful, lean and intuitive automated business Processes that can be used by...

Quality Management System Software User Group Meeting 2016- SOLABS

Building SOLABS’ User Community: Part II

SOLABS Community - 06.01.2016

Every year for the past several years, SOLABS has hosted a User Group Meeting (UGM), both as an educational and social gathering and for users to get the pulse of their industry peers and Quality in general. SOLABS’ Director of Sales and Marketing Ericka Moore sat down to speak with us recently about the 2016 edition of the UGM, and to...