The Challenge Of Managing Regulatory Submissions & Correspondence
Life science organizations produce large volumes of documents necessary for submitting applications to regulatory agencies. They need to have records of those documents as well as all related communications from sites around the world. This creates a situation that can be rather daunting.
Sponsors must first make sure all documents are going through the proper review and approval cycle and that controls are in place to meet regulatory requirements such as 21 CFR part 11. Once the documents are published and ready for submission to the regulatory agency, they are typically stored on a file share. Although that file share has access controls in place, it will not have granular-level access controls.
Delivering Biologics With A Difference
In this webinar you will learn about delivering intravenous-dosed biologics in an aseptically-filled intravenous bag and increase your understanding of the business drivers and potential value added with this strategy.
MAb Manufacturing: Where Are We Headed, Cost Or Capabilities?
Following the discussion on monoclonal antibody (MAb) processing, partly conflicting observations can be made: some push costs in the foreground of process technology discussion, while others emphasize robustness and peace of mind (low risk).
Digital Signatures: Enabling Compliant Collaboration and Streamlined Corporate Governance
In this webinar, we’ll focus on the middle office where life sciences organizations can achieve tangible operational improvements and cost savings.
PAT-Enabled Process Optimization & Control
PAT is a risk-based strategy for designing, analyzing and controlling manufacturing processes. The Critical Process Parameters (CPPs) are identified in line with the definition of the Critical Quality Attributes (CQAs) of intermediates or final products. PAT offers a number of tools for measuring and controlling these CPPs.
Sartorius has the right choice of solutions you need: discover our world of Synchronized PAT Solutions.