Insights On Regulatory Compliance

  1. Deviation And Change Control In Pharmaceutical Manufacturing 9/20/2024

    Explore deviation management and change control in the pharmaceutical industry, the elements of Corrective and Preventive Action (CAPA), and how to best approach these three interconnected processes.

  2. Validation Of A Sterilization Process: Part 3 9/9/2025

    Explore the full scope of sterilization activities and gain key insights into cycle development and validation using BI and BB methods to ensure product sterility and regulatory compliance.

  3. Handling Protocols: Key Considerations In The Highly Potent API Market 5/12/2025

    Explore the growing role of highly potent active pharmaceutical ingredients in oncology and Antibody-Drug Conjugates to highlight manufacturing challenges, safety protocols, and opportunities for CDMOs.

  4. Contamination Control Strategy With QRM Principles 11/19/2024

    Contamination Control Strategies (CCS) have long been a main concept, but advancing requirements and regulatory expectations create a challenge. Learn how to be effective and compliant with your CCS.

  5. A Practical Packaging Components Checklist For Emerging Biotechs 6/20/2024

    A proactive approach to packaging development can ultimately ensure a smoother launch. Explore five key considerations when selecting components for your injectable drug product.

  6. Navigating Regulatory Compliance: A Success Story In The Pharma Industry 4/10/2025

    Reveal how one pharmaceutical facility overcame strict cross-contamination rules and space limits without costly building modifications to ensure operational continuity.

  7. Safely Navigating The Transition From MDD To MDR 7/25/2025

    If devices are integral to positive patient outcomes, device partners must play an integral role to ensure regulatory compliance is achieved in the most effective way.

  8. Taking A Best Practice Approach To Contamination Control  9/21/2025

    Implementing the EU GMP Annex 1 requires a holistic, evolutionary Contamination Control Strategy built on standardization, data analytics, and continuous improvement for a zero-defect mindset.

  9. Streamline Single-Use Assembly Design To Enhance Efficiency 10/15/2025

    Single-use systems offer major benefits in pharma manufacturing, but design complexity brings challenges. Learn how to overcome issues like scalability and quality assurance with integrated strategies.

  10. How Software-Enabled Manual Visual Inspection Can Boost Your ROI 7/14/2025

    Unlock hidden cost savings in pharma manufacturing. Learn how software-enabled manual visual inspection enhances efficiency, data integrity, and regulatory readiness without full automation's capital expense.