08.27.25 -- Defining Product Roles And Navigating FDA Approval With Monika Swietlicka

Hear from a 21 CFR Part 11 expert with nearly 20 years of experience supporting pharmaceutical, diagnostic, and medical device companies with implementing solutions and systems to ensure compliance.

Dr. Rachel Sherman, former Principal Deputy Commissioner of the FDA, explains the rules of engagement for working with today’s FDA.

The regulatory environment for cell and gene therapies (CGTs) is evolving rapidly, requiring sponsors to adopt a more strategic, integrated development approach.

Explore the latest in lentiviral vector release testing, which covers biosafety, regulatory insights, and QC strategies to ensure patient safety and accelerate your path to clinic.

Companies still relying on paper-based manufacturing are falling behind. Discover how digital transformation boosts efficiency, and ensures compliance in this essential shift toward smarter operations.

Minimizing endotoxins is crucial in pharma manufacturing. Explore rigorously tested, low-endotoxin products for cleanroom and sterile applications.

The FDA wrapped up 2024 with 3 notable approvals. Harpreet Singh, MD and CMO, provides a recap.

Navigate the complexities of PUPSIT with expert guidance. Discover best practices for assembly design, regulatory compliance, and troubleshooting common challenges in sterile filtration environments.

Strengthen risk mitigation strategies while ensuring regulatory alignment. Gain valuable insights into best practices and proactive approaches for building a robust and future-ready CCS.

Discover how streamlined workflows and enhanced collaboration between data managers and medical reviewers can boost clinical trial efficiency, improve data quality, and ensure patient safety.

While organizations adapt to evolving safety and efficacy standards for mRNA, collaboration remains essential for navigating challenges like differing regional requirements, and analytical complexities.

Drug shortages have increased the burden on compounding pharmacies. Robotics and automation can streamline processes, and ensure quality to address challenges faced by these facilities.

Cell and gene therapies are witnessing rapid advancements, but significant challenges remain for their commercialization due to regulatory hurdles, manufacturing barriers, high costs, and safety concerns.

Gain insights into the nuances of cleanroom conceptual design for GMP operations and learn how an integrated approach can ensure regulatory compliance, functionality, and environmental performance.