Presenter: Charlie Wakeham, APAC GxP Compliance Manager at Waters Corporation

Charlie Wakeham has more than 20 years of industry experience developing and validating computerized systems for regulated production and laboratory environments. As Waters Corporation’s GxP Compliance Manager, she provides practical and pragmatic computerized systems validation assistance and data integrity consultancy to regulated companies implementing Laboratory Informatics in Asia Pacific (APAC) countries.

Some of Charlie’s career highlights are:

Training APAC regulators including TGA and Medsafe
Presenting at 2017 PIC/S Inspectors Seminar held in Taiwan
Contributing to seven GAMP Good Practice Guides
Awarded ISPE Max Seales Yonker Member of the Year 2019

Charlie has been active within ISPE GAMP since 2001. She was a founder member of GAMP UK, and former Secretary of GAMP Europe. She currently serves as Secretary of GAMP Global Council and as part of the GAMP Data Integrity SIG Leadership Team.

Abstract

It takes time, money and resources to generate laboratory data, so any loss of data is a direct financial loss to your regulated company as well as a major compliance risk.

This presentation will explain how to simplify record retention using a Scientific Data Management System to capture data from your laboratory instruments. It will discuss key data protection activities needed to protect data from loss or disaster, and how to plan proactively for disasters to significantly reduce their impact on laboratory operations. This presentation aims to help lab managers and quality managers to understand the risks to their regulated data, how to set up safeguards to reduce those risks, and the technologies and solutions that are needed to recover the data if a disaster occurs.

From the everyday consumer to scientists in the laboratory, we all rely on accurate information to make critical decisions.

Waters Corporation is the world's leading specialty measurement company focused on improving human health and well-being through the application of high-value analytical technologies and industry leading scientific expertise.

Our decisions and actions are guided by two simple words – Deliver Benefit. Our founder, Jim Waters, coined these words to encapsulate the idea that we should positively impact our customers, employees, shareholders and society at every opportunity.

Driven by that ethos for over sixty years, Waters has continually pioneered chromatography, mass spectrometry and thermal analysis innovations. Whether it’s discovering new pharmaceuticals, assuring the safety of the world’s food and water supplies, or ensuring the integrity of a chemical entity in production, we are constantly working with our 40,000+ customers to change the world.

With a global workforce of more than 7,000 employees, Waters operates in 35 countries, including 15 manufacturing facilities and with products available in more than 100 countries. Our diverse organization is well-positioned to Deliver Benefit through innovations that enhance human health and well-being.

Waters Workshop

Durable Data – Securing Your Instrument Data

Abstract