Onderstepoort Biological Products invites service providers from suitably registered companies for the following: GMP Refresher Program for Professionals training as per the specifications. Course Content to cover the following: • Quality management of biopharmaceutical commercial product formulations; • Personnel expertise in GMP Raw Material for GMP Manufacturing; • Premises and equipment required for GMP; • Documentation and records: Proper documentation filing for GMP; • Production protocol for GMP Written Procedures and Deviations, Sampling and Testing of In-Process Materials and API Products, Specifications and Reprocessing; • Principles of Calibration and Qualification How to Perform a Failure Mode Effect Analysis (FMEA); • Process Validation Life Cycle Approach (PV); • Principles of Cleaning / Decontamination Validation (CV) Control of Microbiological Contamination; • Pharmaceutical utility systems: HVAC, Purified Water, WFI, Compressed air, Nitrogen etc; • cGMP: Corrective and Preventive Action (CAPA) in Medicinal Product; Manufacturing - Including Root Cause Analysis Quality Control (QC) operations; • Technology transfer principles. Please confirm the closing date. (Offerte №77349678it)