Empower Tips: Ask Me Anything about Compliance and Data Integrity
According to a recent article in the American Pharmaceutical Review, “In 2020, numerous warning letters were issued from the FDA citing data integrity violations. Common findings violate principles of ALCOA+, 21CFR Part 11 and the FDA’s data integrity guidance document. Additional findings include deletion or manipulation of data, aborted sample analysis without justification, invalidated OOS results without justification, failure to document work contemporaneously and uncontrolled documentation." If you need help navigating the complex and evolving inspection landscape or are concerned about remote inspection requirements due to the pandemic, please join us for this live webinar where we will share expert insights and will address your compliance and data integrity concerns.
In this webinar, you will have the opportunity to question Waters’ leading experts in Empower Software, in data integrity, and in regulatory compliance. Waters understands how important these topics are for regulated companies and have supplied a list of additional resources below. All questions are welcomed during the webinar, and reviewing some of the linked materials before the webinar may help you to construct in-depth questions to really challenge the experts and substantially improve your own knowledge about how Empower supports compliance.
Presenter: Neil Lander (Principal Product Manager, Informatics, Waters Corporation)
Neil has worked for Waters Corporation since 1994 and has held a variety of positions including Technical Support Specialist, Technical Trainer, Manager Customer Education and currently, Principal Marketing Manager focusing on Informatics solutions. He provides internal support for Empower Chromatography Data System and is focused on developing laboratory software solutions that help organizations achieve their scientific and operational objectives. Prior to joining Waters, he was an analytical chemist where he gained experience in both the cosmetics and specialty chemical industries.
Presenter: Heather Longden (Senior Marketing Manager, Pharmaceutical Intelligence, Waters Corporations)
Heather Longden is the Senior Marketing Manager, Pharmaceutical Intelligence for Waters Corporation. After a number of years in training, supporting and selling Waters Software, Heather's current role is as a specialist in compliance to e-record regulations, acting as a resource to the global informatics community at Waters and the users of all Waters informatics products. This involves helping design the compliance into Waters informatics products and services, attending and presenting at specialist conferences, keeping up to date on the latest interpretations and amendments to the regulations and disseminating this information to the Waters field and corporate organizations.
Presenter: Charlie Wakeham (APAC GxP Compliance Manager, 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.
