Newsletter | October 17, 2024

10.17.24 -- When Your Regulatory Findings Need Quality Risk Management Action

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Let Us Handle Your Buffer Preparation

Thermo Fisher Scientific is here to support you with the buffer preparation in your manufacturing workflow. Leaving the non-core activities to us enables you to focus on the patient therapy development. Our capabilities cover off-the-shelf products like WFI, NaOH, NaCl, or EtOH, a library of the most frequently used buffers that are made-to-order, as well as fully customized buffers.

FOCUS ON REGULATORY

What To Do When Regulatory Findings Need Quality Risk Management Action

More than half of all recent warning letters issued by the FDA include citations for absent or incomplete risk assessments. This article examines what regulators are looking for.

Ask The Expert: 21 CFR Part 11 Compliance

Hear from a 21 CFR Part 11 expert with nearly 20 years of experience supporting pharmaceutical, diagnostic, and medical device companies with implementing solutions and systems to ensure compliance.

5 Areas To Focus Your QRM Strategy For Sterile Drug Products

Explore five areas that can form part of a quality risk management strategy to ensure the compliant manufacturing of sterile drug products.

Strategies For Navigating Raw Material And Process Changes

Explore the regulatory and technical elements involved in changing biopharmaceutical manufacturing processes, particularly in regard to the use of different chromatography resins

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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

Data Quality, Collection, Storage, And Security

AI/ML systems perform best when trained on quality data. Here, our panelists discuss what to consider when it comes to AI and collecting, protecting, and storing data in biomanufacturing.

Rapid Thermal Stability Screening Of High Concentration Biologic Drugs

Explore data demonstrating the effectiveness of a rapid screening-differential scanning calorimeter as well as its detection limits and the range of concentrations suitable for DSC analysis.

If Your Data Could Talk...

Explore two examples where data contextualization plays a critical role in a biopharma manufacturing environment, and learn how to get your data to speak the same language across different systems.

ANALYTICS & QUALITY SOLUTIONS

Validation And Quality Management Software Platform - CAI

The Industrial DataOps Solution For Industry 4.0 - HighByte

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