Insights On Regulatory Compliance

  1. Digitizing Quality Management: The Key To Avoiding FDA Recalls In Life Sciences 1/13/2025

    Explore the need for digital quality management systems to ensure compliance as life science companies face rising FDA recalls.

  2. ICH Q9 Revision 1: Enhancing Quality Risk Management 8/12/2024

    ICH Q9 Revision 1 advances the framework of Quality Risk Management (QRM) in the pharmaceutical industry, by addressing technological advancements and evolving regulatory expectations.

  3. Don't Let Seals Break Your Batch: A Risk-Based Approach To Column Maintenance 7/28/2025

    Optimize biopharmaceutical manufacturing by implementing risk-based seal maintenance. Tailor replacement protocols using data and advanced monitoring for enhanced efficiency and compliance.

  4. Accelerate And Enhance Biomanufacturing Operator Training 5/28/2025

    Unlock the power of blended operator training and learn how combining digital tools with hands-on instruction reduces errors, boosts retention, and empowers your workforce for real-world production success.

  5. Mobilizing Compliance: USP 797 And 800 Pharmacy Trailer Fleet For VA Hospitals 6/6/2024

    VA hospitals across the US are undergoing renovations to bring their facilities into compliance. The challenge was to design and manufacture a fleet of self-sufficient mobile compounding pharmacies.

  6. FAQs On The Revised EU GMP Annex 1: Volume 1 3/5/2025

    The revised GMP Annex 1 guidelines emphasize quality risk management, enhanced environmental monitoring, and data integrity, which aim to minimize contamination and ensure patient safety.

  7. Essential Insights Into Pharmaceutical Product Release, Part 1 Of 2 12/27/2024

    Pharma product release ensures drug quality, safety, and regulatory compliance by evaluating manufacturing and quality processes. It’s a critical, comprehensive process essential for FDA approval and patient safety.

  8. Characteristics Of Environmental Residues And Protocols For Removal 4/1/2025

    Examine disinfectant residue characteristics, impacts, and removal challenges in cleanrooms, as well as learn about the practical requirements for maintaining cleanliness standards and addressing these residues effectively.

  9. 5 Key Principles Of Cleanroom Particle Counting 6/24/2025

    Discover the five essential principles of cleanroom particle counting and how they ensure compliance, prevent contamination, and protect product quality in highly regulated manufacturing environments.

  10. The High Requirements Placed On Pharmaceutical Labeling Solutions 8/18/2025

    Regulators are implementing new rules to combat counterfeit medicines. Learn how serialization, tamper-evident seals, and track-and-trace solutions protect products and patients from risk.