Risk Management
Features
- 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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Analytical Services | Bioanalytical Services | Bioassay Development | Capsules | Extractables and Leachables | Facilities | Fill/Finish | GMPs/GCPs | Lyophilization | Methods Development | Process Development | Process Validation | QA/QC | Risk Management | Scale-up/Technology Transfer | Toxicology | Validation
Process Mapping
Why we need a “robust” process mapping systemPaolo Mazzoni, PTM Consulting 03.07.12
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Analytical Services | Aseptic Processing | Bioanalytical Services | Bioassay Development | Chemistry | Drug Delivery | Drug Development | Extractables and Leachables | Facilities | Fill/Finish | GMPs/GCPs | Inspections | Laboratory Testing | Logistics | Methods Development | Parenterals | Process Development | QA/QC | Risk Management | Serialization | Supply Chain | Toxicology | Validation | Vials
The Glass Quandary
Glass breakage, delamination and compatibility with biologics have boosted interest in novel materials in pharma packagingFran DeGrazio and Diane Paskiet 01.23.12
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Cold Chain Management | Extractables and Leachables | Facilities | GMPs/GCPs | Logistics | Methods Development | Process Development | QA/QC | Risk Management | Serialization | Supply Chain | Validation
Global Life Sciences Companies Turn to 3PLs
Flexibility, expertise and financial benefits can accrueScott Cubbler 11.14.11
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Analytical Services | Bioanalytical Services | Bioassay Development | Capsules | Drug Development | Extractables and Leachables | Facilities | Fill/Finish | GMPs/GCPs | Information Technology | Inspections | Lyophilization | Methods Development | Process Development | Process Validation | QA/QC | Risk Management | Toxicology | Validation
Quality by Design: Product & Process Development
Product & Process DevelopmentDr. Siegfried Schmitt 11.14.11
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Breaking News | Drug Development | GMPs/GCPs | Inspections | Promotions & Moves | Regulatory Affairs | Risk Management
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Capsules | Drug Delivery | Extractables and Leachables | Facilities | Fill/Finish | Formulation Development | GMPs/GCPs | Lyophilization | Process Development | Risk Management | Solid Dosage/Semi-solids | Vials
Design for Manufacturability and Scale-Up
What pharmaceutical companies should know about DFMSURich Sitz and Stephen Stein 09.07.11
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Drug Development | Regulatory Affairs | Risk Management
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Breaking News | Promotions & Moves | Risk Management
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Breaking News | Promotions & Moves | Regulatory Affairs | Risk Management
Advanced Clinical Names Regulatory Affairs Director
Eman Albazzaz has been appointed executive director of Regulatory Affairs to lead regulatory and pharmacovigilance efforts for Advanced Clinical.07.13.11
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Chemistry | Microbiology | QA/QC | Risk Management
Contract Laboratory Partnerships
How to make a partnership work with a contract pharmaceutical testing laboratoryDonald Singer, GlaxoSmithKline and Thomas J. Edkins 06.06.11
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Aseptic Processing | Capsules | Extractables and Leachables | Facilities | Fill/Finish | GMPs/GCPs | Inspections | Laboratory Testing | Lyophilization | Microbiology | Process Development | Regulatory Affairs | Risk Management
QbD, PAT, and the Future of Microbiology
Environmental monitoring with RMMMichael J. Miller, Ph.D. 04.29.11
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Aseptic Processing | Capsules | Extractables and Leachables | Facilities | Fill/Finish | GMPs/GCPs | Inspections | Laboratory Testing | Lyophilization | Microbiology | Parenterals | Process Development | Process Validation | Regulatory Affairs | Risk Management | Validation | Vials
Aseptic Processing Update
What�s new in aseptic processing, validation, and contract manufacturing?Hal Baseman 04.05.11
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Cleaning Validation | Extractables and Leachables | Facilities | GMPs/GCPs | Inspections | Methods Development | Microbiology | Parenterals | Process Development | QA/QC | Risk Management | Validation
Risk-MaPP and Multi-Use Facilities
Managing cross-contamination risksStephanie A. Wilkins, PE 03.07.11
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Analytical Services | Bioanalytical Services | Bioassay Development | Biologics, Proteins, Vaccines | Biosimilars | Clinical Trials | Drug Development | Drug Discovery | GMPs/GCPs | Inspections | Methods Development | Process Development | Regulatory Affairs | Risk Management | Toxicology
Outsourcing for Biosimilars
Achieve regulatory compliance & gain competitive edgeJeffrey J. Freitag, M.D. and William Egan 01.24.11
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Extractables and Leachables | Facilities | GMPs/GCPs | Inspections | Logistics | Methods Development | Process Development | QA/QC | Regulatory Affairs | Risk Management | Serialization | Supply Chain | Validation
Global Supply Chain Quality Management
Prepare now to ensure compliance in FDA�s new reign of enforcementBob Rhoades 01.24.11
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APIs | Inspections | Process Validation | Regulatory Affairs | Risk Management | Supply Chain | Validation
Increased FDA Scrutiny of Purchasing / Supplier Controls
Multiple perspectives on shifting regulatory burdensBraulio Ortiz, Michael Neaves 10.08.10
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Biosimilars | Clinical Trials | Process Development | Risk Management | Supply Chain
Biotechnology Trends & Outsourcing
How has biopharma impacted the outsourcing market?Lou Schmukler and John Korte 10.08.10
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APIs | Aseptic Processing | Cleaning Validation | Excipients | Process Development | Process Validation | Risk Management | Validation
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Breaking News | Industry News | Risk Management
Pilgrim, GRS To Deliver Enterprise Solutions
Pilgrim Software, Inc. has entered a strategic partnership with Global Regulatory Services (GRS), a life science consultancy.08.20.10
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APIs | Clinical Trials | Drug Development | Inspections | R&D | Regulatory Affairs | Risk Management
