Compliance
Covering the latest regulatory news and updates.
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Inspections | QA/QC | Regulatory Affairs
FDA Inspection Trends Update
Insulate yourself from risk to achieve success in your FDA inspections.Ben Locwin, Contributing Writer 05.02.22
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Biologics, Proteins, Vaccines | Regulatory Affairs
Phase-Appropriate cGMP Considerations for Cell and Gene Therapy
Readiness to begin GMP manufacturing is a decision point that requires careful consideration.Keith Lamb, Executive Director, Lachman Consultants 05.02.22
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cGMP Manufacture | GMPs/GCPs
Sustainability: A New Threat or Opportunity for CDMOs?
CDMOs must be proactive in adapting to the sustainability standards of pharma companies.Dr. Michele Jermini and Dr. Enrico Polastro, Contributing Writers 05.02.22
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cGMP Manufacture | Facilities | GMPs/GCPs
In Pursuit of Sustainability: How the Biopharma Industry Can Contribute
Applying a sustainable mindset can offer a competitive advantage in both the industry and the community.Henryk Badack, Senior VP Technical Service and Internal Project Management Vetter Pharma-Fertigung GmbH & Co. KG 05.02.22
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Clinical Trials | QA/QC | Regulatory Affairs
Conducting Clinical Trials During the Pandemic: What Did We Learn?
Key takeaways from MHRA's Good Clinical Practice Symposium.David S. O’Connor, Senior Director, Lachman Consultants 04.08.22
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Information Technology | QA/QC
5 Key Characteristics of a Next Generation QMS Solution
Pharmaceutical companies must modernize their QMS to provide equal or greater value in today’s world of digital tools and information.Kari Miller, QMS Regulatory and Product Management Leader, Global Tech Solutions, IQVIA 04.04.22
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Information Technology | QA/QC
Achieving Quality Maturity: 5 Key Characteristics of a Next Generation QMS Solution
Pharmaceutical companies must modernize their QMS to provide equal or greater value in today’s world of digital tools and information.Kari Miller, QMS Regulatory and Product Management Leader, Global Tech Solutions, IQVIA 03.28.22
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Clinical Trials | GMPs/GCPs | Information Technology
Why Decentralized Clinical Trials Remain a Black Box to Most Research Sites
Overcoming complexity, data, and compliance challenges and how sponsors can help sites become comfortable with DCTs.Catherine Gregor, Chief Clinical Trial Officer at Florence Healthcare 03.18.22
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Breaking News | Industry News | Inspections
WuXi STA Passes First EMA Drug Pre-Approval Inspection at Wuxi City Site
The Wuxi City site will start to provide commercial drug product manufacturing service of an innovative medicine for the European market.03.03.22
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Breaking News | Facilities | Industry News | Validation
B. Braun Receives FDA Approval of Daytona Beach Pharmaceutical Manufacturing Site
Increased availability of IV solutions to address shortages stemming from ongoing COVID-19 crisis.02.03.22
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Regulatory Affairs
Improving Public Health
Regulatory considerations around bioequivalence in topical generic drug product development.John Buchan, Life Science Technology Specialist 02.01.22
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Regulatory Affairs
The Future of Pharma
Robert Califf’s appointment to head of FDA is a signal of the future of pharma.Ben Locwin, Contributing Editor 02.01.22
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Information Technology | QA/QC
Advancing Quality Transformation
Best practices for generics manufacturers and CDMOs.Ashley Wentworth, Director, Vault Quality, Veeva Systems 02.01.22
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Biologics, Proteins, Vaccines | cGMP Manufacture | Regulatory Affairs
Pharma Outlook 2022
CPhI report says high manufacturing demand to constrain global ingredients, partnering options and available CDMO capacity.01.14.22
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News | Regulatory Affairs
Ardena Expands Capacity to Satisfy Novavax COVID Vaccine Demand
Site in Södertälje, Sweden will see capacity increases in purification and fractionation of GMP manufacturing.01.13.22
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Breaking News | Industry News | Inspections | QA/QC
WuXi STA Passes First U.S. FDA PAI at Waigaoqiao Site
Included manufacturing facility, equipment, labs, quality management system, tablet production, material handling, computer control systems, and data integrity.01.04.22
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Chemistry | Methods Development | Microbiology | Validation
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Analytical Services | Breaking News | cGMP Manufacture | Industry News | Methods Development | Regulatory Affairs
WuXi STA, Coherent Biopharma Enter Strategic PDC Pact
WuXi STA to provide peptide platform services from drug discovery to commercial manufacturing to support Coherent’s PDC drug candidate development.12.01.21
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Clinical Trials | Drug Development | QA/QC | Regulatory Affairs
Pharmacovigilance: Improving Public Health
A look into modern pharmacovigilance, regulatory role in drug safety, and public health and ADR reporting.John Buchan, pharmasol 11.23.21
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Breaking News | cGMP Manufacture | GMPs/GCPs | Industry News | Inspections
Metrics Contract Services Successfully Completes ANVISA Inspection
For commercial manufacture of a branded oncology drug to be marketed in Brazil.11.16.21
