Kenneth Peleman

Background

About Kenneth Peleman

I’m a QC/QA professional with experience in different aspects of the QA/QC department. My experience ranges from QA tasks such as supplier management, ISO 13485:2016 certification, reviewing and writing SOP’s, special outlines, deviation, change control system, temperature monitoring, etc, while my QC experience is mostly in sterility testing, mycoplasma testing and biological assays. I have lead several validation processes including the validation of disinfectants and dental products and IQ/OQ/PQ of process and manufacturing equipment under FDA/ Health Canada regulation. I assisted in several R&D projects: set up of bioreactors for the production of vaccine, investigation on bait mix composition. Final product release to market for HC, FDA, international markets and product release submissions to CFIA. Knowledge of cGMP, CFIA, USDA, PIC/S, ISO 13485:2016, FDA and Health Canada regulations and performed technician training pertaining to aseptic techniques. I am aware and have been involved in quality processes such as CAPA, OOS/ OOT, NCR and have assisted in annual product quality review (APQR) as well as product complaint handling and supervision of the Pest Control Program.