Compliance
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QA/QC
Three Ways Quality Can Impact a Business’s Bottom Line
The Quality function today is tasked with helping to improve overall company performanceStephen McCarthy, Vice President of Digital Innovation at Sparta Systems 12.05.18
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Cleaning Validation | Validation
Compliance Insight, Inc.
Compliance Insight, Inc. specializes in hands-on FDA Regulatory and Quality Assurance consulting and training for the pharmaceutical, dietary supplement, medical device, chemical, cosmetics, bio-technology and food industries worldwide. Services incl…Cindy Ipach, President 11.28.18
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Clinical Trials | Drug Development | GMPs/GCPs | Information Technology
Update on ICH E6 R2 Guideline for GCP
Patrick Hughes of CluePoints discusses opportunities and advantages of the new guidance and considers possible limitationsPatrick Hughes, Chief Commercial Officer, CluePoints 11.27.18
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Chemistry | Methods Development | Microbiology | Validation
Pace Analytical Life Sciences, LLC
Pace Analytical Life Sciences is a full service contract analytical testing laboratory providing chemistry and microbiology testing services to the pharmaceutical and medical device industries. Services include methods development/validation, raw mat…James Wheeler, james.wheeler@pacelabs.com 11.21.18
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APIs | Breaking News | Facilities | Industry News | Inspections
CordenPharma Completes SafeBridge Recertification
Potent Compound Recertification Audit was conducted at Colorado site11.20.18
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APIs | Serialization | Validation
ATL - Ad Tape & Label
ATL, a 60 year old company, specializes in custom labels and the manufacturing and packaging of die cut disposable components for the medical and pharmaceutical industry. Label capabilities include single-ply, extended content, and multi-panel bookle…Gina Butler, Marketing Manager 11.16.18
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APIs | Process Development | Validation
Rommelag CMO - Holopack Verpackungstechnik GmbH
Rommelag CMO provides you with quick and easy access to BFS technology without having to invest in either the mandatory GMP environment that goes with it or the specialists required to operate and maintain the machines. What we offer is the whole spe…Andreas Haeussner, Director Marketing 11.15.18
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Process Development | Validation
Rommelag CMO - Maropack AG
Holopack Verpackungstechnik GmbH as well as maropack ag are members of the Hansen-Group, the inventor of the bottelpack aseptic filling machines based on the Blow-Fill-Seal (BFS) technology. We offer secure, economical and individualized solutions fo…Andreas Haeussner, Director Marketing 11.15.18
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Capsules | Supply Chain | Validation
Pharma Tech Industries
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QA/QC | Serialization | Supply Chain
Don’t Just Tick the Box, Think Outside Of It
How a quality-first approach to serialization can deliver long-term value beyond compliance.Martin Van Trieste, CEO, Civica Rx and Board Member, rfxcel 11.13.18
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Bio News | cGMP Manufacture | Facilities | Industry News | Inspections
GRAM Completes Successful FDA Inspection
Following eight day inspection, GRAM was found to be in compliance with cGMP, with no Form 483 observations issued11.09.18
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Aseptic Processing | Formulation Development | Information Technology | Logistics | QA/QC
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Validation
Pilgrim Quality Solutions, an IQVIA company
Pilgrim Quality Solutions is a leading global provider of enterprise quality management software and services for the Life Sciences and other highly regulated industries. For more than 20 years, Pilgrim has automated thousands of processes that ensur…Sandy Carson, MarCom & Events Manager 11.08.18
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Bio News | Industry News | Inspections
Avance Completes Successful FDA Inspection
Houston facility was successfully inspected by the U.S. FDA on October 1 through October 4, 2018.10.31.18
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Bio News | Industry News | Promotions & Moves | Regulatory Affairs
CROMSOURCE Appoints Regulatory Services Director
David R. Dills has more than 28 years of experience in the medical device and pharmaceutical industry10.26.18
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Breaking News | Industry News | Inspections
Almac Completes HPRA Inspection at its European Campus
Can now support analysis of commercial drug product and provide flexible secondary labelling and packaging solutions10.26.18
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APIs | Breaking News | Cytotoxics and High Potency Manufacturing | Industry News | Inspections | QA/QC | Regulatory Affairs
Recipharm Audit Results in Licence Restriction
Five non-critical highly potent products from the Ashton-u-Lyne, UK site suspended due to potential cross contamination risk10.25.18
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Bio News | cGMP Manufacture | Industry News | Inspections | Scale-up/Technology Transfer
SEA Vision Launches HarleNir
Near Infrared Hyperspectral vision system can inspect an entire batch on the manufacturing line in a fully automated fashion10.22.18
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Bio News | cGMP Manufacture | Facilities | Industry News | Inspections
Almac Completes Successful HSA Inspection
Underwent regulatory inspection by the Health Sciences Authority of its facility in Singapore10.22.18
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Regulatory Affairs
Reporting CPPs to FDA
Importance of identifying critical process parameters in original submissions to FDA.Aloka Srinivasan, Ph.D. Lachman, Consultant Services 10.10.18
