INSIGHTS ON REGULATORY COMPLIANCE

• Are You Aligned With FDA's Computer Software Assurance Methodology?

  Discover how Computer Software Assurance updates the FDA's Computer System Validation (CSV) framework to promise streamlined validation and cost reduction despite industry uncertainty.

• Why The Latest Technology Helps Navigate Evolving Regulator Expectations

  By embracing data-driven insights, companies can confidently navigate complexities, reduce risks, and deliver trusted products to global markets.

• Environmental Monitoring Vs. Good Aseptic Technique

  Review the standards and regulations promoting a cohesive environmental program, and explore manual compounding in laminar flow hoods, through to filling lines, in both open and closed systems.

• Boston Scientific: Enterprise Asset Management

  Examine how Boston Scientific uses RAM to centralize asset management to boost compliance, efficiency, and visibility for maintenance, calibration, and validation across facilities.

• Bioequivalence In Topical Generics: Regulatory Considerations

  9/2/2025

  Regulators are increasingly favoring in vitro methods to prove bioequivalence, though differing guidelines and a new focus on matching reference product structures pose challenges.

• Doubling Up For Speed In Biomanufacturing

  12/12/2025

  Accelerate drug development and reduce risk with parallel operations. Learn how leveraging CDMO partnerships while building internal capabilities can cut costs and speed your path to market.

• Interview With Pharma Analytics Field Application Specialist - Sandi True

  11/6/2025

  Hear Sandi True, a Field Applications Specialist discuss helping customers navigate challenges often encountered when evaluating and implementing Residual DNA Quantitation, Mycoplasma Detection, and Microbial Identification Assays.

• Leachables Method Development, Validation And Relevant ICH References

  5/16/2025

  It is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.

• Enhancing Viral Vector Sterile Filtration: Process Efficiency And GMP Alignment

  11/4/2025

  Explore filtration strategies that improve viral vector yield and quality, with insights on AAV and lentivirus workflows, plus practical guidance for implementing PUPSIT in line with requirements.