09.14.23 -- Biosimilars Forum Statement On CMS Announcement Of Drug Negotiation List

Over the past 18 months, biotech has undergone a major transformation, down from the “sugar high” of the biotech bull market and steady flow of capital in the early pandemic years. Arda Ural of Ernst & Young provides key tips for your biotech to survive and thrive during the current market correction until investment in the sector cycles back to more prosperous times.

Achieving audit readiness is not a snapshot in time but an ongoing commitment to maintaining day-to-day compliance and quality standards. Let's explore how your manufacturing and quality teams can align efforts with these six practices to maintain audit and inspection readiness at all times.

Computer software and systems validation testing is used to validate software under GxP environments. Parts 1 and 2 of this article series shared Agile methodology with regard to the phases of planning, team structure and collaboration, software architecture, and more. In this final installment, the author discusses software release, configuration and change management, CAPA, and more.

Efficiently managing a diverse supply base is crucial for drug companies to maintain growth, profitability, and compliance. While the procurement function can be organized under various executives, the relationship between the CFO, procurement, legal, and buying departments is very important.

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