Newsletter | October 24, 2024

10.24.24 -- What's Next After FDA's DSCSA Extension?

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Webinar: Analytical Solutions To Help Accelerate Bioprocessing Success

Join us on November 1, 2024 to explore analytical solutions for enhancing bioprocessing success. We’ll cover available media analytics, their benefits, and limitations, and how to select the right service for your goals. Key topics include addressing performance optimization challenges, understanding metabolite and lipid analysis, and utilizing customized analytics and prototyping for media manufacturing to improve cell growth, productivity, and product quality. Click here to learn more.

FOCUS ON ANALYTICS & QUALITY

Computer Systems Validation Pitfalls, Part 1: Methodology Violations

When computer systems validation work is not performed according to protocol instructions — by cutting corners on quality outputs with the focus on profit as the main driver — this can result in drug and device companies losing profits and efficiencies.

FOCUS ON ANALYTICS & QUALITY

ICH Q12 Implementation: Regulatory Intelligence And PACM Agility

Here, we outline a practical framework designed to assist companies in implementing ICH Q12 from day one, enabling them to realize its benefits early on and paving the way for continuous improvement.

Leveraging ISA-95 In A Pharma 4.0 World

Explore core elements of the ISA-95 specification and how life sciences manufacturers can apply them within an integration solution designed for industrial data modeling, delivery, and governance.

ANALYTICS & QUALITY SOLUTIONS

The Aizon Difference For Life Science Manufacturers - Aizon

BD FACSDuet Premium: Sample Preparation System - BD Biosciences

FOCUS ON REGULATORY

What's Next After FDA's DSCSA Extension?

Facing growing pressure from industry and Congress, FDA extended its enforcement deadline yet again, which has important implications for manufacturers.

FOCUS ON [REGULATORY - INDUSTRY INSIGHTS]

Ensure A Seamless Handover Stage In The Technology Transfer Process

Understanding the key elements in the handover stage of a technology transfer is critical to your success. This is an overview of the Handover Stage of PDA TR-65.

REGULATORY SOLUTIONS

Software Solutions To Advance And Expand Your Capabilities - Advanced Instruments, Inc.

Tech Transfer And The Need For Digital Transformation - IDBS UK HQ

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