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Celia Brown

Celia Brown is the Vice President, Sales and Marketing at ZenQMS.
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Recent Posts

The Impact of COVID-19 on Quality Management for Life Sciences Companies

Posted by Celia Brown on Apr 20, 2020 9:47:05 AM

With travel bans and stay-at-home orders in place throughout the US and many other countries, life sciences companies are struggling to maintain GxP compliance under increasingly challenging circumstances. Employees are working remotely- and so are FDA inspectors and auditors. And new regulations are being rolled out frequently in hopes of expediting the drugs, devices, and vaccines supporting the treatment and prevention of COVID-19.  

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Topics: Security, eQMS, Business Continuity

Quality Management in Times of Uncertainty

Posted by Celia Brown on Mar 31, 2020 7:06:15 AM

As COVID-19 continues to spread across the globe, governments urge citizens to self-quarantine, and the U.S. economy faces an uncertain future, the life sciences industry is under more pressure than ever. Pharmaceutical and healthcare companies continue to work toward the development of a vaccine and therapies for the respiratory infection that was declared a pandemic by the World Health Organization last week. And the FDA is rolling out updated policies to streamline the path to an effective vaccine and protecting the public from fraudulent products. 

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Topics: quality leaders, QLF, Business Continuity

The Challenges of a Manual Quality Management System

Posted by Celia Brown on Mar 9, 2020 9:11:00 AM

Karin Ashkenazi has more than 15 years of experience in the life sciences industry, including experience as a quality leader for clinical laboratories. Prior to joining ZenQMS last year to lead the Quality team, Karin worked in a laboratory with a paper-based quality management system (QMS). They were a small organization with a limited budget and so they initially felt that a paper-based system was their only option. 

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Topics: Manual QMS, biopharmaceutical, video

How to Properly Audit a Vendor in a Regulated Environment

Posted by Celia Brown on Mar 5, 2020 10:50:04 AM

Auditing a vendor starts long before you actually step into their office to perform the audit. For example, one of the first things you should look for when selecting a vendor is how willing they are to offer customers access to their platform- that may include performing demos of their solution, providing a sandbox environment or free trial, and responding to questions/ inquiries. 

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Topics: eQMS, QLF, video

Quality is a Competitive Advantage for this CRO

Posted by Celia Brown on Mar 3, 2020 9:37:00 AM

Background

This U.S. based contract research organization (CRO),  was founded in the early 1980’s and has been committed to cancer research ever since. Quality is at the core of their business model given that their clients are life sciences companies and subject to regulatory compliance and good manufacturing practices (GMP.)  The company is audited multiple times each year by their clients and could be audited by the FDA at any time so it is critical that their Quality Management System is best-in-class. 

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Topics: CRO, case study

What is the relationship between data integrity and quality culture?

Posted by Celia Brown on Feb 24, 2020 1:08:00 PM

Data integrity is at the heart of quality culture and everything we do in the life sciences industry. It is a term that is often used synonymously with regulatory compliance but they are not actually the same at all.  Whether or not you are building- or intending to build- commercial products, the data you are generating will later inform commercial filings and applications that will add value for the business. And so that data- and the ability to defend that data all the way back to the source- is very important. 

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Topics: QLF, quality culture, video, data

10 Tips for Audit Preparation for Emerging Life Sciences Companies

Posted by Celia Brown on Feb 20, 2020 2:33:48 PM

Whether it’s your first or fifth or five hundredth audit, you can never be too prepared. We recently hosted a webinar on exactly this topic, hosted by quality and systems expert Ed Morris. Morris walked through tips for preparation for and day of your audit.  

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Topics: Webinar, best practices, quality culture

Tips for Selecting an eQMS

Posted by Celia Brown on Feb 19, 2020 9:45:00 AM

Sourav (Neil) Banerjee is a Quality Assurance Director with 21-year track record of protecting patient safety and data integrity, with experience in Big Pharma, CROs, and Software vendors. As Director of Quality, he led eQMS implementations from the ground up. Given Mr. Banerjee's deep experience in selecting and implementing eQMS solutions in the life sciences industry, we asked him to share some tips for those who are just getting started or in the midst of their purchasing decision. 

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Topics: eQMS, QLF, video

ISO in the Cloud

Posted by Celia Brown on Feb 17, 2020 12:47:00 PM

bill-oxford-tR0PPLuN6Pw-unsplashRegulated industries, life sciences in particular, have experienced significant changes in the regulatory environment in the past decade. The standards themselves haven’t really changed very much at all- whether it’s ISO 9001 which is focused on quality management, ISO 13485 which is focused on medical device quality management, or the technical standards such as ISO 27001. What has changed over the past 10 years is that the businesses responsible for implementing and maintaining the above standards are increasingly aware that not everyone can apply the same priority to all of the controls. The result is an increased focus on risk-based methodologies. 

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Topics: Quality & Compliance, ISO

The Role of an eQMS in a Quality Culture

Posted by Celia Brown on Feb 13, 2020 9:30:00 AM

 

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Topics: intelligent quality, quality culture, video

ZenQMS offers  a validated Quality Management System (QMS) with fast implementation and full features. Whether you are trying to improve your paper based QMS or build a new electronic Quality Management System, ZenQMS can help you implement an affordable QMS in less time and for less money that you might think.
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