Deal qualification process for Personnel

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hello and welcome to our next executive series video our topic today is Personnel qualifications Aaron Snyder here from Quality Systems explained where we make Quality Systems simple for you if you are new make sure you subscribe to get all the good content we're putting out check out the status bar below for our agenda and stick around to the end for the bonus questions our topic Personnel qualifications comes directly from 211.25 Personnel qualifications in five words Personnel supervisors trainers are qualified Personnel working within the quality management system which covers the manufacturing processing packing or holding of a drug product must have the necessary education training and experience to perform their jobs correctly [Music] the same goes for supervisors Who oversee operations that happen within the quality management system there must be job specific training for each person working within the quality management system and they have to have training records for all of the work constructions and procedures that they use on a daily basis every individual working within the quality management system must have current good manufacturing practice training industry practice is to give this C GMP training at least annually all trainers delivering training within the quality management system must have documented qualifications for the areas where they are performing the training and finally each organization must have the adequate number qualified Personnel to ensure that they can effectively maintain their quality management system so how do I know this is working well first there is a procedure that outlines how a specific positions education training and experience is determined documented achieved and maintained second once an individual is placed into a position there is job specific training on all work instructions and Sops that they need to use in a day-to-day basis either employees go through annual GMP training which is delivered by qualified personnel and then finally the organization has enough qualified Personnel to ensure that the quality management system is effectively maintained so how do I know it's not working well first the procedure for determining Personnel qualifications is not established or it's not effectively established second employees are hired and placed in positions and not given any job specific training they're not trained to the Sops and more constructions that they are going to use on a daily basis third employees aren't given training on good manufacturing practices for the frequency of that training is not adequate they don't retrain frequently enough to establish a good quality culture fourth trainers are not qualified they don't have documented qualifications in the areas that they are training fifth the organization does not have an adequate number of qualified Personnel to maintain their quality management system and now for the bonus questions which group has the responsibility and Authority for ensuring Personnel have the necessary education background and training for their position second what is the process for training individuals once they are moved into a new position and then finally how often do we give good manufacturing practice GMP training to all personnel thank you for watching please like subscribe share and comment send any questions to me at qms.jedi gmail.com this is Aaron Snyder from Quality Systems explained making Quality Systems simple for you