Good Laboratory Practices (GLPs) Comparing and Contrasting GMP

Non-clinical laboratory studies in which tests article are studied in test system under laboratory conditions to determine their safety.

Medical Device Adverse Event Reporting Systems in EU, Canada and US

Medical device firms’ obligation doesn’t end upon obtaining a marketing clearance, approval, or certificates. Medical device manufacturers are required to report adverse events to the authorities (e.g., Competent Authorities, Health Canada and US FDA), where applicable. To achieve compliance and to remain compliant with the adverse event reporting requirements, it is imperative that medical device manufacturers […]

High degree of Assurance in its Manufacturing Process to Justify Commercial Distribution of the Product

Focuses on how to establish a systematic approach to implementing statistical methodologies into a process validation program consistent with the FDA guidance.