Data Reporting, Compliance and Integrity – Webinars and Online Events

A laboratory automation/digitisation strategy, alongside senior management support, funding and resourcing, is crucial for defining the steps required to automate the laboratory over several phases. The objective of this webcast is to highlight ways to ensure that your investments in laboratory informatics applications are sound and long-lasting.

A laboratory automation/digitisation strategy, alongside senior management support, funding and resourcing, is crucial for defining the steps required to automate the laboratory over several phases. The objective of this webcast is to highlight ways to ensure that your investments in laboratory informatics applications are sound and long-lasting.

Even with robust quality systems governing your analytical laboratory and a strong data integrity (DI) program in place, you may still be nervous about preparing for a regulatory inspection. What will the inspectors want to know? What will they ask? Is your team prepared?

As organizations look to build and execute digital transformation strategies, a major focus is how to improve the scientific experience. To maximize the output of the lab, scientists need to be able to rely on technological advancements, innovative software and improved processes.

Cell-based chimeric antigen receptor (CAR) T cell therapies have rapidly advanced in recent years, with a variety of targets in clinical research and several FDA approved products already on the market.

Ancillary materials (AMs), also called raw materials in Europe, are components, reagents, and materials used in the manufacturing of cell, gene, and tissue-engineered (CGT) therapies but are not intended to be present in the final product formulation.

Cell therapy is a transformative cancer treatment that utilizes genetically modified cells from a healthy donor or patient's own immune system to attack cancer cells, but manufacturing these cells represents a major challenge for the industry.

In this webinar, data integrity expert Bob McDowall explains how to ensure the integrity and compliance of reported data, from sampling to reporting.

New trends and challenges are being identified as more cell and gene therapy institutions move toward clinical trials and into commercialization. Closed manufacturing systems are designed to minimize contamination risks and reduce ISO cleanroom requirements. In combination with digital connectivity, these systems enable repeatable, trackable, and GMP-compliant manufacturing processes.