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Analytical Services | Information Technology | Laboratory Testing
Welcome to the 21st Century
More tools for changing the way we do things.Emil W. Ciurczak, Contributing Writer 05.09.22
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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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Biologics, Proteins, Vaccines
Reflections on 40+ Years in Biomanufacturing
Howard Levine’s suggestions for those coming up.David G. Jensen, Contributing Writer 05.02.22
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Clinical Trials | Information Technology | R&D
Indian CROs Get Pandemic Tailwinds
New rules to ensure timelines, trial data quality.S. Harachand, Contributing Writer 05.02.22
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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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A Primer on Supplier Quality Agreements
Having Supplier Quality Agreements in place offer both Clients and Suppliers a better chance of success.Ben Locwin, Contributing Writer 04.04.22
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Analytical Services | Bioanalytical Services | R&D
Some Tools to Build A PAT/QbD Program
This month we look at R&D technology applied to process understanding and control.Emil W. Ciurczak, Contributing Writer 04.04.22
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The 90 Day Test
You must ace your move to leadership in 3 months.David G. Jensen, Contributing Editor 04.04.22
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Drug Discovery
Indian Drug Makers Ramp Up Discovery Research
CDMOs augment capabilities.S. Harachand, Contributing Writer 03.08.22
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Biologics, Proteins, Vaccines
Setting the Record Straight on Vaccines
Science’s greatest strength is also its greatest PR weakness.Ben Locwin, Contributing Editor 03.08.22
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Analytical Services | Bioanalytical Services | Drug Development
Since It Isn’t Working, Let’s Do It Even More
Reforming an old system and moving into the 21st century with PAT, QbD and CM.Emil W. Ciurczak, DoraMaxx Consulting 03.08.22
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Fabrications that Fizzle
Common misrepresentations don’t do you justice.David G. Jensen, Contributing Editor 03.08.22
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5 Trends Shaping the Year
Plus: The 22nd Annual Manufacturing Supplement and Parenteral Market Trend ReportTim Wright, Editor 03.08.22
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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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Analytical Services | Bioanalytical Services | Laboratory Testing
The Right Tool for the Right Job
More process analysis instruments.Emil W. Ciurczak, DoraMaxx Consulting 02.01.22
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Two Levels of Trust
Building a team that can inspire themselves.David G. Jensen, Contributing Editor 02.01.22
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A New Era of Technology
Looking at mRNA-based technologies, early phase clinical supply trends and advancing quality transformation.Tim Wright, Editor 02.01.22
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Pharmaceutical Packaging Trends
Lukas Spanier, Director of Packaging Operations at Recipharm’s facility in Monheim, Germany, discusses trends in the pharmaceutical packaging industry.Tim Wright, Editor, Contract Pharma 11.09.21
