James Jardine

4 weeks ago | cellandgene.com | Peter H. Calcott |James Jardine

FOCUS ON REGULATORY & COMPLIANCEThe U.K.'s MHRA has issued a new regulation to allow for decentralized manufacturing of cell and gene therapies (advanced therapeutic medicinal products), describing modular and point of care manufacturing. It becomes effective July 23, 2025. Insights From The FDA's New FAQThe FDA's new FAQ offers crucial insights into best practices, from regulatory meetings to quality control and preclinical studies. Dive in for expert guidance.

Oct 16, 2024 | outsourcedpharma.com | Louis Garguilo |Peter H. Calcott |Rebecca Coutts |James Jardine

Webinar: Reducing Risks by Outsourcing Your OSD Manufacturing and PackagingJoin Ropack on October 23rd as we explore how outsourcing can facilitate access to advanced equipment, streamline production scaling, and minimize risks related to supply chain disruptions and regulatory challenges. Whether considering outsourcing or currently engaging in outsourcing, we will provide valuable insights to help you make informed decisions that align with your operational and strategic goals.

Oct 9, 2024 | pharmaceuticalonline.com | James Jardine

By James Jardine, GxP Lifeline Editor, MasterControl FDA product recalls can be a devastating blow. With increasing frequency and severe consequences, it's imperative for companies to prioritize prevention. This article delves into the root causes of recalls and explores effective strategies to mitigate risks. Discover how a robust quality management system (QMS) can serve as a cornerstone in preventing recalls.

Oct 9, 2024 | cellandgene.com | James Jardine

By James Jardine, GxP Lifeline Editor, MasterControl FDA product recalls can be a devastating blow. With increasing frequency and severe consequences, it's imperative for companies to prioritize prevention. This article delves into the root causes of recalls and explores effective strategies to mitigate risks. Discover how a robust quality management system (QMS) can serve as a cornerstone in preventing recalls.

Oct 8, 2024 | cellandgene.com | James Jardine

By James Jardine, GxP Lifeline Editor, MasterControl Product recalls in the life sciences industry pose significant risks, including financial losses, reputational damage, and potential legal repercussions. To mitigate these risks and protect patient safety, organizations must address the root causes of recalls and implement proactive prevention strategies. This article explores the critical role of a robust Quality Management System (QMS) in preventing recalls.