Cause and Root Cause1.0 PURPOSE: This procedure describes the structured approach and methodology to conduct an investigation of any discrepancies in GMP…Aug 14, 2024Aug 14, 2024
Corrective and Preventive Action Plan (CAPA)1.0 PURPOSE: This procedure ensures that discrepancies in GMP compliance/quality systems are investigated, corrective actions are taken…Aug 14, 2024Aug 14, 2024
Change Control Management Procedure1.0 PURPOSE: To ensure that any change related to quality system, manufacturing, testing, and distribution are reviewed, assessed, and…Aug 14, 2024Aug 14, 2024
What is data integrity? SOP for Data integrity1.0 PURPOSE: This procedure ensures that all manual and electronic data generated during the GMP processes and implemented through the…Aug 14, 2024Aug 14, 2024
Good Documentation Practices (GDPs) and ALCOA Plus Principles for Data Integrity in PharmaceuticalGood documentation practices that include entries and corrections to documents, responsibilities, and training requirements and also good…Aug 14, 2024Aug 14, 2024
ISO Certification; ISO 27001The Importance of ISO Certification for Medical Devices / Why iso certification is importantAug 14, 2024Aug 14, 2024
21 CFR PART 11: OVERVIEW-USFDA21 CFR Part 11 outlines the federal requirements that help to ensure that electronic records are trustworthy, reliable, and generally…Aug 14, 2024Aug 14, 2024
Drug Registration; European MarketThe European pharmaceutical market is one of the largest and most regulated markets in the world. To ensure that drugs are safe, effective…Aug 14, 2024Aug 14, 2024
Medical Devices Directive 93/42/EECThe Medical Devices Directive (MDD) 93/42/EEC has been a cornerstone of regulatory requirements for medical devices in Europe, ensuring the…Aug 14, 2024Aug 14, 2024
Regulations for Medical DevicesIn the rapidly evolving field of healthcare technology, Certified Medical Device Professionals (CMDPs) play a crucial role in ensuring the…Aug 14, 2024Aug 14, 2024
