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American Pharmaceutical News In Review
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August 30, 2019
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  Advances in Cleaning Validation with a Data Integrity Compliant System
Advances in Cleaning Validation with a Data Integrity Compliant System
TOC has long been identified as an efficient and effective way to monitor cleaning validation and verification processes. Using novel techniques with complementary data can provide insight into the trends and data. But such triangulation requires careful management of data to ensure that current Data Integrity guidance documents and regulations are met. Thus, deploying technology is only half of the process and aligning that technology to today’s data management requirements is equally critical. This talk will discuss how Data Integrity regulations affect you and how TOC & conductivity measurements can offer insight to your cleaning validation program.

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» Industry News
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  Fasenra Granted Orphan Drug Designation
AstraZeneca announced the FDA has granted Orphan Drug Designation to Fasenra (benralizumab) for the ... read more »
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  AbbVie Discontinues Rova-T R&D Program
AbbVie announced a Phase 3 trial evaluating Rova-T as a first-line maintenance therapy for advanced ... read more »
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  FDA Warns of Liver Injury with Mavyret, Zepatier, Vosevi
The FDA has received reports that the use of Mavyret, Zepatier, or Vosevi to treat chronic hepatitis... read more »
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  VenatoRx Initiates Enrollment of Cefepime/VNRX-5133 Phase 3 Trial
VenatoRx has initiated enrollment in its Phase 3 trial of cefepime/VNRX-5133 in patients with ... read more »
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  Daiichi Sankyo Reports Positive Initial Results from Bempedoic Acid / Ezetimibe Study
Daiichi Sankyo Europe GMbH announced positive initial results from the 12-week Phase 2 bempedoic ... read more »
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  Horizon Therapeutics Names Executive VP, Chief Business Officer
Horizon Therapeutics has named Andy Pasternak executive vice president, chief business officer, ... read more »

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» Featured Articles
Phase-Appropriate Application of Biopreservation Best Practices to Support Regenerative Medicine Advanced Therapy Products
A cell therapy is defined as the administration of intact living cells to patients for the treatment... read more »
What Should a Start-up Biotechnology Company Know about Microbiology?
In calendar year 2018, the FDA approved a record 62 novel drugs, with the Center for Drug Evaluation... read more »
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» Featured Video
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  Watch Video: Sartorius Stedim Biotech Paul Priebe talks about Single-Use Technologies at Interphex 2019
Sartorius Stedim Biotech Paul Priebe Interview at Interphex 2019 read more »
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  Watch Video: Data Management-Particle Measuring Systems
Particle Measuring Systems Profile Video read more »

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» Featured Products
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  TruCLEAN Pro Cleaning & Disinfecting System
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  i-Series Integrated HPLC Systems
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» Featured Whitepaper
Meet Hound: three lasers make particle ID a breeze
Hound can identify a wide range of contaminants including organic, inorganic, protein, and elemental particles using a combination of automated microscopy, Raman and LIBS. A fully customizable ... read more »
Single-Use Process Platforms Help Biomanufacturers Reduce Costs
There are many new challenges facing those involved in the manufacture of biopharmaceuticals. read more »

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| Events
EVENT
  Outsourcing in Clinical Trials Southern California
La Jolla, CA –  09/24/2019
The leading Outsourcing conference series returns to San Diego for its 7th year in September 2019. With a focus on providing delegates with practical ...
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EVENT
  SMi’s 10th Annual Biosimilars Conference
London, UK –  09/24/2019
SMi Group are delighted to announce the 10th annual Biosimilars Conference taking place on 25th and 26th September 2019. This year’s event will be our...
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