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 ...

Despite their frequent interchangeable use, understanding the distinction between validation and qualification is critical in pharmaceutical environments. Validation is a broader concept encompassing ...

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 ...

The various cleaning validation processes adopted by the drug manufacturers in pharma and biopharmaceutical companies is a significant aspect in determining how safe the drugs and medical products ...

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 ...

Pharmaceutical manufacturing requires defining quality target product profiles and critical quality attributes (CQAs) to ensure desired product quality. Process development identifies critical process ...

Today's injection mold manufacturers are much more than 'just moldmakers.' As OEMs - particularly those in the medical and automotive industries - become more and more dependent upon their supply ...

For more than 15 years, Aldo Vidinha has worked at the intersection of engineering, quality, and regulatory strategy in the ...

COLUMBUS, Ohio, Dec. 18, 2023 /PRNewswire/ -- Andelyn Biosciences, Inc., a pioneering and patient-focused cell and gene therapy Contract Development and Manufacturing Organization (CDMO), announced ...

The generation of clinical-grade cellular products encompasses complex processes that are tightly regulated under current good manufacturing practices (cGMP) and requires adequate cell manufacturing ...

Metrohm’s response to Analytical Instrument Qualification is contained within the Metrohm Compliance Services document, while the most detailed level of documentation offered for AIQ is the IQ/OQ.