Aspects of this philosophy spilled over to some analytical instrument qualification, mirroring the interpretation of FDA process validation — testing a parameter once at OQ stage and three times at PQ ...

The author explores differences between two qualification documents, the draft guidance from FDA "Process Validation: General Principles and Practice" and the ASTM E2500-7 standard "Guide for ...

This 2-day course guides attendees through equipment qualification, calibration, and computer system validation processes from planning to reporting. It also explains regulatory requirements in ...

Despite their frequent interchangeable use, understanding the distinction between validation and qualification is critical in pharmaceutical environments.

For sake of audit, a qualification report can be created to indicate that the employee has met his or her training needs. If divided like this, the change control and system validation must ...

Integri, a Clear2Pay company and leading provider of expertise and test tools for payment, ticketing and mobile applications, today announces it has been selected by EMVCo, the EMV standards body ...

HONG KONG, Feb 23, 2023 - (ACN Newswire) - On February 21, Gotion High-tech was officially granted the Volkswagen Cell Test Lab qualification certificate. This certification marks the recognition ...

Dublin, Jan. 13, 2023 (GLOBE NEWSWIRE) -- The "Latest Process Validation Guidance Requirements course (FDA and EU Annex 15: Qualifications and Validation)" training has been added to ...

The qualification process involves defining safety goals, conducting hazard and risk analyses, developing functional safety concepts, and performing rigorous development, verification, and validation ...

This seminar will help attendees understand the instrument qualification and system validation processes and will provide instruction on how to prepare for FDA audits and how to become part 11 ...