Validation, Commissioning & Design White Papers & Case Studies
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Biotech Files NDA Following Risk-Based Mock Inspection
6/14/2023
See how the preventative approach an emerging biotech company took to mitigate risks and identify potential concerns before their FDA inspection and NDA submission ultimately led to success.
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De-Risk Development: Nonclinical Strategy And Study Design
5/18/2023
Whether you are a researcher, scientist, or industry professional, access these insightful guides and checklists that provide valuable advice and best practices for planning and executing nonclinical studies.
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Aseptic Processing: How To Safely Handle APIs
5/4/2023
How can pharmaceutical manufacturers work with parenteral products to ensure the safe handling of APIs?
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What Does Pharma 4.0 Mean To Cell and Gene Therapy Drug Manufacturers?
4/10/2023
Explore the benefits of Pharma 4.0 for CGT companies along with the challenges they may face when implementing the convergence of people, systems, and data within a singular network.
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How Successful Tech Transfer Can Help Fast-Track NDA Approval
4/4/2023
Examine the first-time-right tech transfer and phase-3 registration batch manufacturing process which led to a biotech receiving NDA approval for its novel compound followed by a successful commercial manufacturing partnership.
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An Introduction To MES For Cell And Gene Therapy Manufacturers
3/29/2023
What are manufacturing execution systems, and why are they so crucial for cell and gene therapy manufacturing?
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How To Achieve Digital Quality Management In Life Sciences
3/6/2023
See poll results illustrating how quality experts in Life Science industries prioritize digitalization, compared to steps actually being taken to the future at this time.
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Cultivate Innovation And Growth At Smart, Connected Facilities
3/6/2023
As the US and Europe continue to lead the way in addressing a growing demand for healthcare products, explore how the global biotechnology sector is maintaining momentum and confronting future challenges.
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PlantPAx Distributed Control System Reduces Downtime For Mallinckrodt
3/6/2023
Learn how the nation's leading supplier in prescription pain medication completely upgraded their control system, resulting in greater diagnostic/troubleshooting information and reducing downtime.
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IT Changes Implemented To Overcome Future Manufacturing Challenges
2/27/2023
Learn how Pfizer and Ferring improved their reporting and batch information management with Rockwell’s technology.