Regulatory Requirements and Standards for Medical Device Validation & Verification

Presented by: Ritam Priya, Consultant, MDRQ Consulting Manufacturers (including software developers) need to gather objective evidence of performance, safety and efficacy to support both their premarket authorization/registration in different markets and postmarket changes. Regulatory requirements are defined by different regulators for product compliance and different committees like ISO, AAMI and IEC that develop standards to […]

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An Overview of Experimental Designs in HPLC Method Development and Validation

Created by: Prafulla Kumar Sahua, Nageswara Rao Ramisetti b,∗, Teresa Cecchi c,∗, Suryakanta Swaind,Chandra Sekhar Patroa, Jagadeesh Panda Chemometric approaches have been increasingly viewed as precious complements to high performanceliquid chromatographic practices, since a large number of variables can be simultaneously controlledto achieve the desired separations. Moreover, their applications may efficiently identify and optimizethe significant […]

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Validation Of Analytical Methods In A Pharmaceutical Quality System: An Overview Focused on HPLC Methods

Created by: Breno M. Marsona, Victor Concentinoa, Allan M. Junkerta, Mariana M. Fachia, Raquel O. Vilhenaa and Roberto Pontarolo Analytical validation has fundamental importance in the scope of Good Manufacturing Practice (GMP) for pharmaceutical products since it establishes scientific evidence that an analytical procedure provides reliable results. However, even with validation guidelines available it is […]

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