DrugDigest

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

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

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.


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

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

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

 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.


European Laboratory Compliance
Specialist
Agilent Technologies

 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.




Webcasts

Webinar Date/Time: Thursday February 24, 2023 at 11am EST | 10am CST | 8am PST


Unpacking the Science Behind Data Integrity

https://globalmeet.webcasts.com/starthere.jsp?ei=1564898&tp_key=5fb16734d9

In this exclusive Drug Digest video interview, Felicity Thomas and Feliza Mirasol, 

editors, interview experts in solid dosage development and manufacturing. Alex Trombley, OSD Process Specialist/Business Development Manager of Syntegon runs through the benefits of continuous OSD production and some key considerations for containment and operator safety, while an expert [Speaker TBD] from Colorcon highlights the importance of authentication at the dose level.

Alex Trombley, OSD Process Specialist/Business Development Manager, Syntegon

Key benefits of continuous OSD production

State of industry adoption of continuous OSD

Containment technologies in OSD production

Key authentication factors at the dose-level for OSD products


OSD Process
Specialist/Business
Development Manager
Syntegon

 is Syntegon’s Business Development Manager where he is focused on technical support, customer trials, and market development for Huttlin products in North. Alex is experienced in early phase formulation development, process identification, scale-up, and technology transfer and has worked extensively with continuous manufacturing, high shear granulation, fluid bed granulation, tableting, and coating.


Thursday, September 28, 2022 at 11am ET | 10am CT | 8am PT

Thursday, September 28, 2022 at 11am ET | 10am CT | 8am PT

Learn the key benefits of continuous OSD production as well as the importance of authenticating OSD products at the dose-level with experts from Syntegon and Colorcon in this episode of the PharmTech Drug Digest Video Series.

DrugDigest

Articles