Search results for " training"
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Understanding Validation and Technical Transfer, Part 2
The installed and qualified equipment may then be used in start-up and training exercises to ensure everything, including coffee shop staff, is ready for a successful opening day.
Validation of…
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Applying GMPs in Stages of Development
Working closely with your CMO/CRO to identify an accurate timeline for completion, including the necessary training required for employees, can help expedite the time it takes to complete the change r…
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Evaluating Surface Cleanliness Using a Risk-Based Approach
By defining the operators’ qualifications, visual inspection tools and conditions, procedures, and training and retraining activities, a company can quantify and validate the visual inspection procedu…
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Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Operational training will be required, as a minimum, but many supply partners can offer a much wider range of services. Validation requires significant experience and know-how and has the potential to…
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Continuous Processing for the Production of Biopharmaceuticals
The authors review the technologies that may help bioprocessing become a truly continuous operation and present case studies that could contribute to the integration of upstream and downstream platf…
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GMP Challenges for Advanced Therapy Medicinal Products
As a result, it has been designing training course packages aimed at specific target groups, such as cell biology scientists who know about ATMPs but need to learn GMP skills.
The project, whose pa…
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USP Stresses Pharmacopeial Standards at CPhI China
“To address growing demands, USP is committed to helping these companies meet pharmacopeial standards, provide training and certification services to help them comply, and also guide them to contribut…
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Advanced Technologies Facilitate Scale-up and Technology Transfer
“For this model to be successful, the facilities need to be identical in order to facilitate tech transfer, documentation, training, and essentially everything that needs to be commissioned to run the…
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Global Expansion Shapes Drug Oversight
These entities hold conferences and training courses on quality manufacturing and testing, as seen in a program this month on parenteral manufacturing in Istanbul.
The Drug Information Association …
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A Look Ahead at BioPharma Manufacturing and Regulation
BioPharm: Can you comment on the staff training workshops held to date with these centers and their benefit to agency reviewers?
FDA: Agency reviewers have had the opportunity to participate in …