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Learn how using a structured workstream approach to operational readiness will reduce costly delays, bottlenecks, and deviations to accelerate production and release to market. |
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Explore the use of digital solutions in asset performance and reliability through case studies conducted across the pharma and biotech industry. Through these studies we learn the practical applications of new digital technology for facility and asset management. |
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How can partnering with a leading parenteral pharmaceuticals manufacturer help you to culturally change your approach to performing initial and recurring qualifications for equipment and processes and move your project team through accelerated milestones in development? |
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Explore some bumps that have arisen for drug manufacturers working to meet the latest Computer Software Assurance (CSA) guidance drafted by the FDA. This guidance has been used to reduce the effort and cost required to complete large computer system validation projects. |
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It's possible that the implementation of Annex 21 has inadvertently created additional barriers to supply that were not anticipated. Take a deeper look at what Annex 21 entail, what all is involved in the Annex, and what makes the process of meeting these requirements so complex. |
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As part of an ongoing effort to support the adoption of innovative manufacturing technologies, the FDA has introduced new AMT Designation program to accelerate implementation of these technologies, driving speed to patient and enhanced sustainability. |
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The FDA has provided guidelines for the translation of studies conducted by non-US testing facilities, including an expectation that the translator be trained in English and experienced in native language translations. |
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Takeda GC selected CAI to help rescue a failing CQV project, focusing on the inefficient Vapourized Hydrogen Peroxide Material Air Lock (VHP MAL) loads. The aim was to create more efficient VHP Loads to enhance operational efficiency. |
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