Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...
The life sciences industry operates under uniquely stringent regulatory requirements where technology systems must not only ...
Dublin, May 24, 2024 (GLOBE NEWSWIRE) -- The "Process Validation Guidance Requirements course (FDA and EU Annex 15: Qualifications and Validation) Course" training has been added to ResearchAndMarkets ...
Part Two of our Protecting Complete Chain of Custody Series As we discussed in our last post, the Role of Biobanking in Protecting Sample Chain of Custody, biobanks serve as biospecimen libraries as ...
Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...
Expectations of regulators, sponsors, and investors are met through efficient and well-designed quality systems and the implementation of a suitable development-stage. Several firms have unique ...
Process validation is an extension of biologics development processes. When it comes to outsourcing process validation of biologics, Abel Hastings, director of process sciences at FUJIFILM Diosynth ...
Quality is a difficulty term to define, but most people know it when they see it. A quality product is made well, with integrity and attention to detail. A quality management system (QMS) is a formal, ...
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