INSIGHTS ON QUALITY ASSURANCE

• US GMP (21 CFR 820) Manufactured Oligos For Preclinical Research

  Learn why Custom cGMP Oligos should be considered to ensure oligo products meet the strict standards of MDx, LDTs, and preclinical research.

• Navigating GxP Compliance Challenges

  Learn how to select and manage trusted software suppliers to streamline your digital transformation, mitigate risks, and ensure regulatory adherence. Watch to discover best practices and real-world examples.

• Digital Transformation Essentials: Building A Strong Data Foundation

  In this presentation we discuss the importance of embracing digital solutions, the paradigm shift toward finding data solutions, and the terminology used by digital transformation leaders.

• Eliminating Analytical Bottlenecks And Streamlining Drug Discovery

  Advanced analytical methods play a crucial role in drug development pipelines by providing accurate data for informed decision-making. However, the increasing complexity and volume of data present challenges in managing and analyzing it effectively.

• Developing Effective Procedures

  10/21/2024

  Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.

• The Power And Potential Of RBM In Clinical Trials

  11/8/2023

  Risk-based monitoring increases overall trial oversight by balancing “must-do” data collection and “nice-to-have” data against site and patient burden — and, more importantly, patient safety.

• Key Takeaways From The ISPE Ireland Annex 1 Event

  4/12/2024

  Key insights from the ISPE Ireland Annex 1 Event shed light on challenges and solutions in meeting EU GMP guidelines for sterile medicinal products.

• The Future Of Compliance, Efficiency, And Data Integrity

  5/5/2025

  Explore how eValidation revolutionizes the pharmaceutical industry by enhancing compliance, efficiency, and data integrity, as well as its indispensable role in modernizing traditional validation methods.

• Innovative Strategies For Residual DNA And Viral Titre Quantitation

  5/22/2025

  Discover how digital PCR improves the accuracy of residual host cell DNA and viral titre quantification in biotherapeutic manufacturing to enhance product quality, safety, and regulatory compliance.