Newsletter | May 14, 2024

05.14.24 -- Improving Governance And Compliance With Knowledge Management

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FEATURED EDITORIAL

Improving Governance And Compliance With Knowledge Management

Knowledge management — it’s not just a soulless exercise. In the last part of his series, Hirsh helps bridge the gap between compliance and business needs.

INDUSTRY INSIGHTS

An Introduction To Laminar Airflow Technology In Aseptic Processing

Explore the vital role that laminar airflow technology plays in meeting sterile integrity standards and minimizing contamination risks in pharmaceutical cleanrooms.

Laminar Flow Hoods In The Pharmaceutical And Compounding Industries

Here, we compare and contrast horizontal and vertical airflow hoods and discuss their applications and benefits in the pharmaceutical and compounding industries.

Predictive Modeling Of Concentration-Dependent Viscosity Behavior

Review a modeling approach employing artificial neural networks using experimental factors combined with simulation-derived parameters plus viscosity data from 27 highly concentrated mAbs.

How To Avoid Delays In Clinical Supply: Strategies For Comparator Sourcing

Learn how sponsors can work effectively with clinical suppliers for accurate forecasting and comparator sourcing.

Round 2: Mastering NDA Submission And A Resubmission Rescue Mission

This biopharmaceutical company had to overcome a trial master file (TMF) transfer from a previous licensee, staff turnover, and then a resubmission of its NDA.

What Are Organ-Chips?

Explore Organ-on-a-Chip technology and how it is paving the way for the next generation of drug development and research.

Pharmaceutical Solid-State Studies

Solid-state characterization meticulously analyzes the physical properties of a drug in its solid form. Understand how this analysis is integrated throughout the drug development lifecycle.

Optimizing CMO Partnerships

Industry experts discuss best practices and tips across a range of topics, including program management, automation, and secondary services.

Reaching BLA Success: Fast-Track Approach To Process Characterization

Discover how knowledge of microbial processes and process characterization understanding can be used to design targeted BLA programs while managing risks.

Powder Rheology For Pharmaceutical Development

Finding the right formulation for a new product is a challenging part of research and development. Learn about powder rheology, an effective tool for accelerating formulation and development in pharma.

Collaborate With Sponsors, Ensure Compliance, And Secure Product Quality

A top 5 global CDMO implemented cloud based IDBS PIMS for improved manufacturing data collection and information visibility for real-time decision-making.

Collaborative Automated Sample Handler For Headspace Analyzers

Discover a collaborative automated sample handler that eliminates manual sample handling, enabling groups to test larger sample sets and collect statistically significant data while freeing up analysts’ time.

SPONSOR

Webinar: Unstoppable Critical Cleaning To Increase Pharmaceutical/Cosmetic Throughput

Join us on May 20th with Alconox to gain a better understanding of critical cleaning chemistry, critical cleaning limits as well as detection, and how to optimize critical cleaning parameters to optimize throughput. We will share case study examples highlighting the importance of process optimization in achieving optimal cleaning results in pharmaceutical and cosmetic manufacturing. Click here to learn more.

EVENTS

Webinar: Filling the Gap in Sterility Testing: Traceability and 21 CFR Part 11 Compliance

 

Gain insight into the critical role of information capture in sterility testing investigations.

 

Session 1 – May 21st 9:00 AM CEST

Session 2 – May 21st 5:00 PM CEST

SOLUTIONS

Aspetic And Non-Sterile Glove Boxes And Containment Systems For HPAPI Processing

Instrument For Accurate Filter Integrity Testing

Streamlining Content Management And Training With Vault Quality

Analytical Services: Capabilities And Expertise

Integrated Containment And Delivery Solutions

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