Unpacking the Science Behind Data Integrity

Prepare to go beyond GMP to improve corporate data culture and knowledge management in a proactive, not reactive, oversight perspective.

Register Free: https://globalmeet.webcasts.com/starthere.jsp?ei=1589587&tp_key=f458f87a53

Event Overview:

In a highly regulated industry such as pharmaceuticals each company needs to prove the quality of their products by showing data produced during their production processes. Management of records and data by these regulated companies is controlled by data governance, which embraces people, processes, and the technology required for effective data handling. All this leads directly into the production of high-quality drug product. Keeping up with requirements is obviously a vital step, but more generally, prioritizing how to actively demonstrate what controls you have in place to prove trust in the data in your organization, every data lifecycle step, the GxP (IT and non-IT) systems, and all related processes, makes a vital difference in how regulators see your quality management maturity (QMM) but also how both staff and clients see the company itself.

In this webinar learn how to help set controls in your organizations over data, and why efforts spent here are financially rewarding in the long run.

Key Learning Objectives

• Understand how data integrity-related CGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees
• Learn how to do better to manage Data integration within your organization, and how to seamlessly deliver this data to outside partners and also regulators
• Prepare to go beyond GMP to improve corporate data culture and knowledge management in a proactive, not reactive, oversight perspective.

Speakers:

Paige Cane
Pharmaceutical Regulatory Science
Team (PRST) at TU Dublin and
Director and MMD Knowledge
Management Center of Excellence
Merck & Co Inc.

Paige Cane is a member of the Pharmaceutical Regulatory Science Team (PRST) at TU Dublin, as well as Director in the MMD Knowledge Management Center of Excellence at Merck & Co Inc. Paige brings over 30 years’ experience working in a regulated environments (including Pfizer, Wyeth, Genetics Institute, Monsanto and USDA/USCS), and has been responsible for developing and implementing KM programs, quality systems for GLP, GCP, and GMP, electronic records/electronic signatures programs, and automation validation methodologies.

Garry Wright
European Laboratory Compliance
Specialist
Agilent Technologies

Garry Wright is European Laboratory Compliance Specialist at Agilent Technologies. Garry has 25 years of experience working within regulated pharmaceutical environments and providing compliance guidance to regulated companies across Europe.


Register Free: https://globalmeet.webcasts.com/starthere.jsp?ei=1589587&tp_key=f458f87a53

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