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October 16, 2019

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New Data Integrity-Based Validation for TOC Software

Validating software is an essential part of meeting today’s Data Integrity requirements -- yet many facilities fail to apply the same validation standards and protocols to software as they do to instruments. A new validation support package for TOC software is now available to specifically address Data Integrity and compliance to 21 CFR Part 11. Don’t be the subject of Data Integrity warning letters.

	Industry News

Innoveix Issues Voluntary Recall of all Sterile Compounded Drug Products
Innoveix Pharmaceuticals is voluntarily recalling all sterile compounded drug products, within ... read more »

Relmada Announces Results from REL-1017 Study for Treatment Resistant Depression
Relmada reported top-line data from a Phase 2 clinical study evaluating the safety, tolerability and... read more »

Target ALS, AFTD Announce Partnership for Drug and Biomarker Development
AFTD and Target ALS announced a partnership and call for proposals to identify treatments and ... read more »

Therapix Biosciences Announces Positive Data from THX-210 Study
Therapix Biosciences announced positive results in its pre-clinical study evaluating THX-210, a ... read more »

Immunic Completes Enrollment for Phase 2 EMPhASIS Trial of IMU-838 for RRMS
Immunic announced the final patient was enrolled and randomized in the company's phase 2 EMPhASIS ... read more »

Akorn Receives FDA Approval for Betamethasone Dipropionate Lotion
Akorn has received a new ANDA approval from the FDA for betamethasone dipropionate lotion USP (... read more »

	Featured Articles

Multidrug Antimicrobial Resistance Testing and Fecal Transplant Therapy Risks Following the death of one patient and another falling seriously ill (reported in June 2019), the U.... read more »

It’s Not Easy Being…a Raw Material SMEeeeeee If I wanted to talk to you about raw materials, would your ears perk up? No? You’re not alone. In ... read more »

	Featured Announcements

[Register today!] The Life Cycle of Big Data in a Contamination Control Strategy
PMS
Data collection and analysis is a critical component of a robust contamination control strategy. The... read more »

	Featured Video

Watch Webinar: Supporting CAR-T Process Performance through Advanced Analytics
Learn how Sartorius' Umetrics Suite of Data Analytics Solutions support and improve CAR-T process performance. Autologous cellular therapies, CAR-T in... read more »

Watch Webinar: New USP Monographs – Solving Analytical Challenges in Pharmaceutical Analysis
Watch Webinar: New USP Monographs – Solving Analytical Challenges in Pharmaceutical Analysis read more »

	Featured Products

Facility Monitoring System
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TruCLEAN II Compact Flat Mopping System
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	Featured Whitepaper

Simultaneous extraction of mycoplasma, mouse minute virus (MMV), and vesivirus nucleic acids from a single sample
Early detection of cell culture contamination is critical to prevent further contamination of facilities and requires fast, reliable assay methods. Here we describe an integrated nucleic acid ... read more »

Free SFC Application Compendium
Agilent InfinityLab SFC Solutions allow you to separate and quantify complex mixtures faster and more efficiently than ever before. This compendium demonstrates the power and application reach of SFC.... read more »

	Events

World Vaccine Congress
Barcelona, Spain – 10/29/2019
The World Vaccine Congress is an award winning series of conferences and an exhibition that has grown to become the largest and most established ... event details »

Lab Informatics Summit
Boston, MA – 11/18/2019
The 15th Lab Informatics Summit will bring together senior IT and Lab Informatics leaders from large and small-mid pharma companies to discuss best ... event details »

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