Insights On Regulatory Compliance

31. Supply Chain Corrective Action Report Checklist 2/7/2025

    Discover how to shape a corrective action plan that provides a structured method for resolving supply chain issues, emphasizing root cause analysis, accountability, and continuous improvement.

32. Best Practice Approaches To Operational Readiness 12/11/2024

    Learn how to implement a focused operational readiness model that goes beyond traditional construction and startup schedules. Discover how this approach can reduce timelines and improve project success.

33. How Document Control Software Supports Digital Transformation Efforts 10/9/2024

    Embrace digital transformation in pharma manufacturing with advanced document control and quality management systems to enhance compliance, streamline processes, and accelerate time to market.

34. Biomanufacturing Operator Training And Solutions 5/20/2025

    Discover a hands-on biomanufacturing training program that empowers operators with essential skills, boosts efficiency, and supports innovation in the fast-paced biopharma industry.

35. The GxP AI Podcast: Unveiling the AI Model Validation Cheat Sheet 5/28/2025

    Discover how AI is revolutionizing biotech manufacturing as Toni and Christian reveal the story, strategy, and regulatory impact behind their innovative AI model validation cheat sheet.

36. Innovations In Mycoplasma And Sterility Testing For Biopharma 5/22/2025

    In this webinar, our expert speakers will discuss the types of analytical testing that can be effectively employed in the early stages of therapeutic development and subsequently scaled to meet production challenges.

37. ICH Q2 And ICH Q14 Revisions Clarify Analytical Methods For Biologics 8/30/2024

    Learn about the revisions to ICH Q2 and Q14 that provide clarification on analytical methods for biologics, aiming to ensure accuracy, reliability, and consistency in testing these products.

38. Nitrosamine Analysis: Solutions For Risk Management And Analytical Testing 8/22/2024

    Testing for nitrosamines is essential in the development and manufacturing of Active Pharmaceutical Ingredients (APIs) and drug products to ensure safety and compliance.

39. Five Steps To Implementing CSA 12/17/2024

    Explore how the FDA’s CSA guidance simplifies computerized systems validation by emphasizing risk-based approaches, reducing documentation burdens, accelerating testing, and enhancing compliance.

40. The Guide To Understanding The Impact On Cost Of Poor Quality 2/4/2025

    This guide unveils the hidden financial burdens of subpar products and provides a roadmap to improvement. Explore nine distinct categories of poor-quality costs and learn strategies to mitigate them.