Search results for " documentation" in Articles / App Notes

Article Design of Experiments for Analytical Method Development and Validation
• Define the steps in the method and any associated documentation. • Determine the responses that are aligned to the purpose of the study. • Complete a risk assessment of all materials, equipm…

Article FDA and EMA Extend QbD Parallel-Assessment Pilot Program
FDA and the European Medicines Agency (EMA) have extended the joint pilot program for the parallel evaluation of quality-by-design (QbD) applications for two years beginning April 1, 2014. In the jo…

Article Best Practices in Adopting Single-Use Systems
The system should arrive with the required regulatory documentation, ready to use. At one time, bioprocessors made routine modifications to single-use systems at their facilities. These days, it is be…

Article Operational Excellence: More Than Just Process Improvement
Working together, the quality and operations groups were then able to dramatically improve the rate of right-first-time documentation. The quality function created new roles designed to partner with o…

Article Essentials in Quality Risk Management
Clear action owners, implementation timelines, and an effective documentation and review process are needed to make the needed and identified changes happen. QRM TOOLS QRM tools are…

Article A Look Ahead at BioPharma Manufacturing and Regulation
The FDA talks about the changing scope of regulatory science. Regulatory science underpins innovation and practices in drug manufacturing. The most common definition of r…

Article Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech. By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…

Article Sterilization Trends for Single-Use Consumables
Generally, documentation is provided with each component/system. Three key trends: capacity, complexity, and process control The increasing use of SU technologies for biologic drug manufacturing h…

Article Webinar: Establishing a CHO-K1 cell line and cell line development process for biotherapeutics markets
But how can you meet rapid timelines when the cell line development workflow is challenged by documentation needs, commercial use rights, and regulatory scrutiny? Join Cytiva’s webinar on Febru…

Article Current Techniques and Challenges Presented in Scaling Between Bioreactors
cell culture   In this video, Andreas Castan, Strategic Technology Partnerships Leader at Cytiva, discusses the current techniques and challenges in scaling between bioreactors.  …

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