Be an skilled in Risk Management (ISO 14971) and QMS (ISO 13485) actions and create PFMEA, DFMEA, CEA, PHA like a professional!
Description
Who this course is for:
This course is designed to show you all the pieces that it’s good to know to turn into a Topic Matter Skilled (SME) in Risk Management and High quality Management System (QMS) inside Medical system and Pharmaceutical business.
No matter your present abilities and expertise, after taking this course, you may be snug speaking to consultants in medical system business about High quality administration techniques (QMS) and threat administration (RM) requirements and rules.
You’ll learn to draft advanced RM paperwork resembling PFMEA, DFMEA, Profit-Risk Evaluation, Submit Market Surveillance Report (PMSR), Medical Results Evaluation Report (CEA) from the scratch! Realizing this abilities will set you aside from the gang and you’ll simply land you six-figure jobs in a reputed medical system firms.
You’ll be effectively versed in guidelines, rules and requirements for medical system industries internationally resembling ISO 14971 (Risk Management, ISO) , 21 CFR 810 (FDA, USA), RDC 40/2015 (Anvisa, Brazil), EU 2017/745 MDR, MHLW MO 169 (PMDA, Japan) and TGR 2002 (TGA, Austrialia) and be capable of discuss them in conferences, interviews and even with auditors.
