Risk Management
- All
- APIs
- Aseptic Processing
- cGMP Manufacture
- Cleaning Validation
- Clinical Trial Materials
- Cytotoxics and High Potency Manufacturing
- Excipients
- Extractables and Leachables
- Facilities
- Fill/Finish
- Lyophilization
- Parenterals
- Process Development
- Process Validation
- Risk Management
- Scale-up/ Technology Transfer
- Solid Dosage/ Creams/ Ointments
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Breaking News | Industry News | QA/QC | Risk Management
Sanofi to Transform its Contracting Foundation
Selects Icertis’ digital platform for cloud management09.01.17
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Risk Management
Mitigating Regulatory Risk for a Global Product Launch
Addressing the critical regulatory challenges life science companies face in today's marketOnline Exclusives Kristin Brooks, Contract Pharma 11.22.16
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APIs | Regulatory Affairs | Risk Management
News Highlights from the 2016 Annual DIA Meeting
Comprehend Launches Clinical Intelligence Suite, Quintiles Launches CGM Service Offering, and more...Online Exclusives07.06.16
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Excipients | Lyophilization | Risk Management
Clinical Manufacturing On Time and Within Budget
For pharmaceutical companies both large and small, the challenges involved in developing new drugs are growing steadily. Regulatory requirements are becoming more complex, and the processes involved have followed suit. Even more innovative manufactur…David Brett, Vetter Pharma International GmbH 06.02.16
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Risk Management
India Revises Biosimilars Guidelines
Stricter quality, safety norms on cardsS. Harachand, Contributing Editor 05.05.16
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APIs | Cleaning Validation | Risk Management | Validation
Setting Health-Based Exposure Limits to Support Pharmaceutical Development and Manufacturing
Health-based exposure limits are needed to support risk assessmentsB.D. Naumann, P.J. Nigro, U. Bruen, L. Parola, D. Cragin and A. Schatz, Merck & Co., Inc. and Ashland, Inc. 05.05.16
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Excipients | Process Development | Process Validation | Risk Management | Validation
Process Development Trends
An approach to process development of pMDIs using cold fill and pressure fill technologySteve Haswell, 3M Drug Delivery Systems 05.05.16
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Risk Management | Supply Chain | Validation
Pharma IT Trends
The challenge of implementing MES technology with increased regulationChristian Fortunel, LZ Lifescience 05.05.16
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Risk Management
Should We Call It Risk or Relevance?
What is the difference and what does it mean?Ben Locwin, Contributing Editor 04.05.16
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Breaking News | Industry News | Risk Management
Survey Says Flex Mfg. to Help with Fluctuating Forecasts
Product launch challenges finds forecasts can be off by more than 50%03.16.16
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Inspections | Risk Management | Supply Chain
Quality Metrics: What Does it Really Mean?
Background, thoughts and the current industry dialogue on FDA’s quality metrics initiativeDr. Mike Long, ValSource 03.09.16
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APIs | Industry News | Logistics | Risk Management | Supply Chain
A Look at DCAT Week ‘16
On the pulse of the pharmaceutical manufacturing value chain, DCAT Week ‘16 will deliver top-flight education programs and networking events.Tim Wright, Editor 01.28.16
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Risk Management
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CRO News | Risk Management
Quintiles Launches Asset Development Planning
IADP aims to facilitate strategic planning process, data analytics and modeling12.14.15
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Industry News | Process Validation | Risk Management | Validation
Grand River Expands Disposable Technology Capabilities
Single-use systems aim to offer cost and time savings, improved safety and quality, and flexibility in process design12.09.15
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Excipients | Process Development | Process Validation | Regulatory Affairs | Risk Management | Validation
Process Validation
Has it changed since the issuance of the FDA and EMA guidances?Peter H. Calcott , Calcott Consulting LLC 10.07.15
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Breaking News | Process Validation | Promotions & Moves | Risk Management | Validation
ValSource’s Michael Long to Lead PDA’s Applied Statistics Interest Group
Inaugural meeting at PDA/FDA joint regulatory conference Washington, D.C. September 28th09.15.15
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Risk Management
Growth of Biosimilars: Implications for Safety and Risk Management
Global biologics market will expand to $250 billion annually by 2020, with biosimilars and non-original biologics commanding 4-10% of that marketSuhasini Sharma, Sciformix Corporation 09.11.15
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APIs | Excipients | Inspections | Risk Management | Validation
Elemental Impurities
Where we were then, where we are now, and where are we going?James Menoutis, Quantex Laboratories Inc. 09.11.15
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cGMP Manufacture | GMPs/GCPs | Process Development | Risk Management
Getting to Yes
The critical attributes CMOs need to demonstrate to win businessEric S. Langer, BioPlan Associates 07.14.15
