Newsletter | September 3, 2024

09.03.24 -- The Influence Of Flows In cGMP Architectural Design

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Webinar: Client Sustainability Directives- CDMO Perspectives

This webinar discusses pharmaceutical industry sustainability initiatives from various perspectives of Contract Manufacturing Organizations. You’ll gain an understanding of current directives and metrics, discuss CDMO strategies to overcome the immensity of the tasks to get started, and identify paths forward to address the directives that ensures a positive outcome for the CDMO, its stakeholders, and the world. Click here to learn more.

INDUSTRY INSIGHTS

What Does The New Annex 1 Mean For The Aseptic Fill/Finish Industry?

The revised Annex 1 focuses on harmonizing regulations across the pharmaceutical manufacturing industry, prompting the industry to strategize to achieve the best compliance method.

6 Reasons To Transition To A Cloud-Based Lab Data Management System

Dig deep into some of the compelling reasons to move from on-premise to a cloud-based laboratory data management system.

The Business Case For Modernizing Validation Management

Explore a framework demonstrating the value of adopting a digital, data-centric approach to validation management to executives and stakeholders.

Strategic CMC Planning Through A Phase-Appropriate Quality Approach

A phase-appropriate quality approach ensures quality activities align with the unique risks and challenges of each development phase. Watch to learn how to apply such an approach to CMC planning.

21 CFR Part 11 Data Management Is The Basis Of Data Integrity

Learn about FDA regulation 21 CFR Part 11 and the critical role it plays in ensuring pharmaceutical and medical product manufacturers properly manage and track their data.

4 Reasons For The Rise In Blister Packaging

Here are the factors that are driving blister to the forefront of pharmaceutical packaging, and at an even faster rate than its current growth.

Getting CMC Right For Emerging Technologies

Establishing a chemistry, manufacturing, and controls strategy that proves a clinical program is tightly controlled and can address risk is critical to avoiding the pitfalls that stall many promising therapeutics.

Harmonizing Regulatory Guidelines For Assay Validation

Explore a detailed process for validating ligand-binding assays, particularly for Fcγ receptor binding analytes or other structural isoforms.

The Impact Of Water Activity Testing On Tablets And Capsules

Watch to gain a comprehensive understanding of water activity testing as well as how to effectively use non-destructive headspace analysis to generate dependable water activity data.

Life Science Success Podcast With Matt Hicks

Federal Equipment's Matt Hicks was interviewed by Don Davison on the Life Science Success podcast. Hear them discuss Matt’s career and how Federal Equipment buys and sells pharmaceutical equipment.

Leveraging Bio-Functional Assays For Charged Variants Characterization

The heterogeneity of a biologic product has implications for the final therapy's safety and efficacy. Explore challenges associated with charged variants, including mAbs and fusion proteins.

FEATURED EDITORIAL

The Influence Of Flows In cGMP Architectural Design

In drug manufacturing facility layout, balancing the roles of layout and procedure plays a critical role. This article examines how the interplay may be resolved, and how this resolution affects facility layout during design.

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The premier event on pre-filled syringes and injection devices brings together key field players to discuss the breakthroughs that are propelling the industry forward. A comprehensive agenda covers critical topics, including sustainability, large-volume injections, digital health, and regulatory compliance. Additionally, the exhibit hall featuring 120+ exhibitors, poster presentations, lightning sessions, lively Q&As, networking activities, and Drug Delivery Innovation Awards make this event a must-attend. Register now

SOLUTIONS

The Advantages Of Creating A Workflow When Monitoring A Cleanroom

Leave Paperwork Behind In Your CQV Process

Liquid Filling And Packaging System For Pharmaceutical Injectable Products

Modular Cleanrooms For Compounding Pharmacies

How To Fill And Empty A Standard Cell Factory System

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