The author describes why statistical significance would impose an unreasonable burden on manufacturers. Validation has been practiced within the global healthcare industry since the early 1970s. While ...

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 authors describe a method-validation-by-design (MVbD) approach to validate a method over a range of formulations using both design-of-experiment and quality-by-design principles to define a design ...

The purpose of this course is to provide candidates with some practical tools for validation - including qualification, process validation and analytical method validation. Validation is a regulatory ...

Dublin, Aug. 15, 2023 (GLOBE NEWSWIRE) -- The "Process Validation Guidance Requirements course (FDA and EU Annex 15: Qualifications and Validation) Course" training has been added to ...

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 ...

DUBLIN--(BUSINESS WIRE)--The "Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation): 2-Day Workshop "conference has been added to ResearchAndMarkets.com's ...

Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...

VP and CISO for Mandiant, helping guide the company's product and solutions strategy and host of the Cyber Security Effectiveness Podcast. Understanding the effectiveness of your company's security ...

The purpose of this course is to provide candidates with some practical tools for validation - including qualification, process validation and analytical method validation. Validation is a regulatory ...