QA/QC
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Drug Development | Industry News | QA/QC
USP Provides Guidelines for rFC Reagent
Recombinant Factor C critical to development of vaccines and other sterile pharmaceutical products.Contract Pharma Staff 06.01.20
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cGMP Manufacture | CRO News | QA/QC
Parexel Launches COVID-19 Risk Mitigation Offering
Four-step methodology aims ensure manufacturers can safely continue manufacturing operations through the COVID-19 pandemicContract Pharma Staff 05.13.20
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Clinical Trials | Information Technology | QA/QC
Managing Clinical Trials Amid the Coronavirus Pandemic
Patrick Hughes of CluePoints discusses the impact on clinical trials and how leveraging data may herald a long overdue paradigm shift in the industry.Online Exclusives Kristin Brooks, Contract Pharma 04.06.20
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Breaking News | Industry News | Inspections | QA/QC | Regulatory Affairs
COVID-19 Update: FDA Foreign Inspections
To postpone most foreign inspections through April, effective immediately03.10.20
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Breaking News | Industry News | Inspections | QA/QC | Regulatory Affairs
FDA Provides Update on Activities Related to Coronavirus
Says it continues to monitor the global drug supply chain by prioritizing risk-based inspections in other parts of the world02.25.20
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Breaking News | Industry News | QA/QC
ALKU Expands Services to Focus on Analytical R&D
Expands services into two groups, Pharmaceutical Quality, Validation, and Compliance, and Pharmaceutical Analytical Research and Development02.21.20
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QA/QC
Quality Management: Preserving and Perpetuating Your Record
CDMOs must ensure that their top priority be delivering the highest quality products.Colleen Herczak, Vice President of Quality, Grand River Aseptic Manufacturing 01.28.20
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Clinical Trials | Drug Development | GMPs/GCPs | Information Technology | QA/QC
Compliance Practices 2020 Predictions
Joe Rymsza of IQVIA shares insights on pharmacovigilance, safety and regulatory trends and the use of advanced technologies in 2020Joe Rymsza , vice president, Pharmacovigilance and Regulatory Technology Solutions, IQVIA 01.13.20
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Breaking News | Packaging & Tracking | QA/QC
Pelican BioThermal Achieves ISO Accreditation
Laboratories in the UK and US receive global recognition for technical capabilities and quality standards12.12.19
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Analytical Services | Industry News | QA/QC
Recipharm Launches Recipharm Analytical Solutions
Stand-alone service offers analytical services including method development, method validation, and stability program design and implementation11.04.19
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Microbiology | QA/QC
Pharma Manufacturing: Methods for Real-Time Microbiology
Vicki Barbur of Battelle discusses real-time microbiology, critical factors determining the rapid method of choice, and accessibility to new technologiesOnline Exclusives Kristin Brooks, Contract Pharma 09.16.19
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Breaking News | Clinical Trials | Industry News | Inspections | QA/QC
FDA Extends CRADA with CluePoints
Aims to further explore a data-driven approach to quality oversight in clinical trials09.11.19
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Bio News | Breaking News | Industry News | Promotions & Moves | QA/QC | Regulatory Affairs
Goodwin Biotechnology Bolsters Quality & Regulatory Capabilities
Names Gerald Orehostky as vice president of quality and regulatory operations08.07.19
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QA/QC | Validation
Considerations for Analytical Method Validation Lifecycle Controls
ICH is set to implement new regulatory guidance dedicated to analytical method developmentPaul Mason, PhD, Lachman Consultants 07.15.19
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Industry News | QA/QC
WDSrx Warehouse Receives VAWD Accreditation
The Pompano Beach, FL facility underwent a compliance review involving operating policies and procedures, licensure verification and facility survey07.09.19
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Clinical Trials | GMPs/GCPs | QA/QC | Regulatory Affairs
Good Clinical Practice: Serious Breach Process
How to assess the significance of the breach, who needs to be involved, and how to report itJane Wood, Principal, YourEncore Quality Center of Excellence 06.27.19
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Industry News | QA/QC
Cytek Biosciences Achieves ISO 9001:2015 certification
Certification applies to Cytek’s headquarters and manufacturing operations in Fremont, CA, for the design, build and support of flow cytometers and accessories05.17.19
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QA/QC
Nitrosamines
How to address these unwelcome guests in the pharmaceutical worldAloka Srinivasan, Ph.D., Lachman Consultant Services 05.07.19
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APIs | Breaking News | Facilities | Industry News | QA/QC
Cambrex Opens QC Lab in Italy
Completes new quality control laboratory for generic API development in Milan04.23.19
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Bio News | Industry News | Promotions & Moves | QA/QC | R&D
Akorn Appoints Global Quality EVP
Mr. Dandy Dorado-Boladeres brings decades of pharmaceutical industry experience and expertise with a focus on operational quality and technical services03.22.19
