Risk Management

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Bioprocess Insider
Key strategies for effective technology evaluationKey strategies for effective technology evaluation

To maintain a competitive edge, life science organizations must leverage technology to enhance decision-making, create innovative business models, and improve customer experiences.

byKim Bennett
Aug 8, 2024
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1 Min Read
BPI Theater presenter
Risk Management
What Unseen Trouble Lies Within Your Processes?What Unseen Trouble Lies Within Your Processes?
byBPI Editors
Jul 31, 2024
Scientist man working
Risk Management
Best-Practice Quality Trends: Going Beyond the Basics in Risk ManagementBest-Practice Quality Trends: Going Beyond the Basics in Risk Management
byLonda Ritchey
Feb 6, 2024
Risk-Based Biologics: CMC Flexibilities in the EU Regulatory System
CMC Forums
Risk-Based Biologics: CMC Flexibilities in the EU Regulatory SystemRisk-Based Biologics: CMC Flexibilities in the EU Regulatory System
byDavid W. Murray
Mar 21, 2023
Learning Management: Evaluation of Retraining Risk at Indian Pharmaceutical Companies
Regulatory Affairs
Learning Management: Evaluation of Retraining Risk at Indian Pharmaceutical CompaniesLearning Management: Evaluation of Retraining Risk at Indian Pharmaceutical Companies
byVenkatesan Jaiganesh, Maria Ioakeimand 1 more
Mar 21, 2023
The State of Quality Risk Management in the Pharmaceutical Industry: Commentary on the Draft ICH Q9 Revision
Risk Management
The State of Quality Risk Management in the Pharmaceutical Industry: Commentary on the Draft ICH Q9 RevisionThe State of Quality Risk Management in the Pharmaceutical Industry: Commentary on the Draft ICH Q9 Revision
byKate Coleman
Dec 12, 2022
Expanding Considerations in Cleaning Validation: Risks Posed By Indirect Product-Contact Surfaces on Pharmaceutical Equipment
Validation
Expanding Considerations in Cleaning Validation: Risks Posed By Indirect Product-Contact Surfaces on Pharmaceutical Equipment
Expanding Considerations in Cleaning Validation: Risks Posed By Indirect Product-Contact Surfaces on Pharmaceutical Equipment
Oct 20, 2022
byTim Sandle
Building a Solid Foundation for a Pharmaceutical Quality System: Presenting QRM and KM As United Enablers
Risk Management
Building a Solid Foundation for a Pharmaceutical Quality System: Presenting QRM and KM As United Enablers
Building a Solid Foundation for a Pharmaceutical Quality System: Presenting QRM and KM As United Enablers
Sep 28, 2022
byMartin Lipa
Managing Host-Cell Proteins: Robust Risk-Assessment Frameworks for Process-Related Impurities in Biological Products
Risk Management
Managing Host-Cell Proteins: Robust Risk-Assessment Frameworks for Process-Related Impurities in Biological Products
Managing Host-Cell Proteins: Robust Risk-Assessment Frameworks for Process-Related Impurities in Biological Products
May 20, 2022
byBrian Gazaille, Christina L. Zuch de Zafra
eBook: Speed to IND — Practical Wisdom for Uncertain Times
Supply Chain
eBook: Speed to IND — Practical Wisdom for Uncertain Times
eBook: Speed to IND — Practical Wisdom for Uncertain Times
Oct 29, 2021
+5
byS. Anne Montgomery, John Hilland 5 more
Risk Determination of Potential Mycotoxin Exposure to Patients: Testing Recombinant Human Factor VII from Transgenic Rabbits
Bioanalytical Methods
Risk Determination of Potential Mycotoxin Exposure to Patients: Testing Recombinant Human Factor VII from Transgenic Rabbits
Risk Determination of Potential Mycotoxin Exposure to Patients: Testing Recombinant Human Factor VII from Transgenic Rabbits
Oct 28, 2021
+2
byGreg Allard, Nick Masielloand 2 more
Preparing for a Virtual Audit
Regulatory Affairs
Preparing for a Virtual Audit
Preparing for a Virtual Audit
Sep 30, 2021
byKate Coleman
No More Sleepwalking: New Mindsets for Manufacturing Cell and Gene Therapies at Commercial Scale
Cell Therapies
No More Sleepwalking: New Mindsets for Manufacturing Cell and Gene Therapies at Commercial Scale
No More Sleepwalking: New Mindsets for Manufacturing Cell and Gene Therapies at Commercial Scale
Sep 30, 2021
byEdwin Stone
Microbiome-Based Therapeutics: Negotiating Key Development Challenges
Manufacturing
Microbiome-Based Therapeutics: Negotiating Key Development Challenges
Microbiome-Based Therapeutics: Negotiating Key Development Challenges
Sep 30, 2021
+1
byAndrew Thomson, Brian Carpenterand 1 more
Risk Considerations for Aging Pharmaceutical Facility Cleanrooms
Facility Design/Engineering
Risk Considerations for Aging Pharmaceutical Facility Cleanrooms
Risk Considerations for Aging Pharmaceutical Facility Cleanrooms
May 21, 2021
byTim Sandle
Emerging Strategies for Drug-Product Comparability and Process Validation: Part 2 — Validation, Legacy Products, and Lifecycle Management
CMC Forums
Emerging Strategies for Drug-Product Comparability and Process Validation: Part 2 — Validation, Legacy Products, and Lifecycle Management
Emerging Strategies for Drug-Product Comparability and Process Validation: Part 2 — Validation, Legacy Products, and Lifecycle Management
Apr 16, 2021
+7
byZahra Shahrokh, Andrew Weiskopfand 7 more
eBook: Buffers — Navigating New Demands on Downstream Raw Materials
Supply Chain
eBook: Buffers — Navigating New Demands on Downstream Raw Materials
eBook: Buffers — Navigating New Demands on Downstream Raw Materials
Mar 31, 2021
+2
byRobert Shaw, Angela Linderholmand 2 more
Cold-Chain Validation: Emerging Vaccines for COVID-19 and Beyond Require More Extensive Evaluation
Vaccines
Cold-Chain Validation: Emerging Vaccines for COVID-19 and Beyond Require More Extensive Evaluation
Cold-Chain Validation: Emerging Vaccines for COVID-19 and Beyond Require More Extensive Evaluation
Feb 5, 2021
+1
byBrian Gazaille, Gary M. Hutchinsonand 1 more
Manufacturability Assessment: A Tool for Effective and Transparent Decision-Making and Efficient Process Development
Risk Management
Manufacturability Assessment: A Tool for Effective and Transparent Decision-Making and Efficient Process Development
Manufacturability Assessment: A Tool for Effective and Transparent Decision-Making and Efficient Process Development
Dec 17, 2020
+5
byKevin P. Brower, Rohan A. Patiland 5 more
Quality Risk Management for Filter Integrity Testing: Compliance with EMA’s Future Annex 1
Sponsored Content
Quality Risk Management for Filter Integrity Testing: Compliance with EMA’s Future Annex 1
Quality Risk Management for Filter Integrity Testing: Compliance with EMA’s Future Annex 1
Oct 29, 2020
byMagnus Stering
Unraveling the Complexities of Technology Transfer
Contract Services
Unraveling the Complexities of Technology Transfer
Unraveling the Complexities of Technology Transfer
Sep 22, 2020
byThomas Chattaway
Life-Science Lawsuits: Learning from the Ordeal
Risk Management
Life-Science Lawsuits: Learning from the Ordeal
Life-Science Lawsuits: Learning from the Ordeal
Jun 11, 2020
byFrank Licata
A Response Plan for Viral Contamination in Bioproduction Facilities
Viral Clearance
A Response Plan for Viral Contamination in Bioproduction Facilities
A Response Plan for Viral Contamination in Bioproduction Facilities
Mar 3, 2020
byYuval Shimoni
eBook: Joining Forces — Industry Collaborations Toward BioProcess Success
Business
eBook: Joining Forces — Industry Collaborations Toward BioProcess Success
eBook: Joining Forces — Industry Collaborations Toward BioProcess Success
Jan 28, 2020
byS. Anne Montgomery, Brian Gazaille
From Supplying Components to Providing Total Solutions: Overviewing Supplier Side Capabilities
Supply Chain
From Supplying Components to Providing Total Solutions: Overviewing Supplier Side Capabilities
From Supplying Components to Providing Total Solutions: Overviewing Supplier Side Capabilities
Oct 28, 2019
byPhilip Cherian
The First Quantitative Industry Assessment of Single-Use System (SUS) Reliability: Raising the Bar for BPSA’s Value to Industry
Single Use
The First Quantitative Industry Assessment of Single-Use System (SUS) Reliability: Raising the Bar for BPSA’s Value to Industry
The First Quantitative Industry Assessment of Single-Use System (SUS) Reliability: Raising the Bar for BPSA’s Value to Industry
Oct 28, 2019
+3
byJanmeet Anant, Jeffrey Carterand 3 more
Risk Management of Biopharmaceutical Operations: End-to-End and Over Lifecycle
Sponsored Content
Risk Management of Biopharmaceutical Operations: End-to-End and Over Lifecycle
Risk Management of Biopharmaceutical Operations: End-to-End and Over Lifecycle
May 15, 2019
+3
byJose Menezes, Madalena R. Testasand 3 more
Recommended Practices for Assuring Integrity of Single-Use Systems
Single Use
Recommended Practices for Assuring Integrity of Single-Use Systems
Recommended Practices for Assuring Integrity of Single-Use Systems
Mar 14, 2019
byBio-Process Systems Alliance (BPSA)
The Complete e-Book of Biosafety Testing
Sponsored Content
The Complete e-Book of Biosafety Testing
The Complete e-Book of Biosafety Testing
Dec 12, 2018
byBPI Contributor
Inactivation of Enveloped Viruses: Seeking Alternatives to a Problematic Surfactant
Viral Clearance
Inactivation of Enveloped Viruses: Seeking Alternatives to a Problematic Surfactant
Inactivation of Enveloped Viruses: Seeking Alternatives to a Problematic Surfactant
Nov 10, 2018
byCheryl Scott
Viral Risk Mitigation: A Global Regulatory Perspective
Sponsored Content
Viral Risk Mitigation: A Global Regulatory Perspective
Viral Risk Mitigation: A Global Regulatory Perspective
Oct 30, 2018
byMartin Wisher
Proposing a Systematic QbD Approach Toward Validated Guidelines for CMO RFI and RFP Processes: Biopharmaceutical Vendor Evaluation and Selection
Contract Services
Proposing a Systematic QbD Approach Toward Validated Guidelines for CMO RFI and RFP Processes: Biopharmaceutical Vendor Evaluation and Selection Minimum Standards (BioVesel)
Proposing a Systematic QbD Approach Toward Validated Guidelines for CMO RFI and RFP Processes: Biopharmaceutical Vendor Evaluation and Selection Minimum Standards (BioVesel)
Oct 15, 2018
+1
byAlison R. Carter, Edward Meinertand 1 more
Accelerated Development, Manufacturing and Monitoring of Viral Vectors
Sponsored Content
Accelerated Development, Manufacturing and Monitoring of Viral Vectors
Accelerated Development, Manufacturing and Monitoring of Viral Vectors
Aug 29, 2018
byBPI Contributor
Host-Cell Protein Risk Management and Control During Bioprocess Development: A Consolidated Biotech Industry Review, Part 2
Risk Management
Host-Cell Protein Risk Management and Control During Bioprocess Development: A Consolidated Biotech Industry Review, Part 2
Host-Cell Protein Risk Management and Control During Bioprocess Development: A Consolidated Biotech Industry Review, Part 2
Jun 20, 2018
+8
byFengqiang Wang, Daisy Richardsonand 8 more
Host-Cell Protein Risk Management and Control During Bioprocess Development: A Consolidated Biotech Industry Review, Part 1 logo in a gray background | Host-Cell Protein Risk Management and Control During Bioprocess Development: A Consolidated Biotech Industry Review, Part 1
Risk Management
Host-Cell Protein Risk Management and Control During Bioprocess Development: A Consolidated Biotech Industry Review, Part 1
Host-Cell Protein Risk Management and Control During Bioprocess Development: A Consolidated Biotech Industry Review, Part 1
Jun 1, 2018
+8
byFengqiang Wang, Daisy Richardsonand 8 more

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