Could someone tell me what this is and where I can find more information about it. I am involved with updating our blood bank compliance and proficiency policies and procedures and would like to utilize all available resources. Thanks for your help.

Could someone tell me what this is and where I can find more information about it. I am involved with updating our blood bank compliance and proficiency policies and procedures and would like to utilize all available resources. Thanks for your help.

We use a computer based AABB cGMP module marketed by Knowledge Trak/ Mediware.http://www.mediware.com/solutions/blood-center-technologies/knowledgetrak

It helps us to maintain compliance on an annual basis.

Essentially you have to have documentation of competence/training of all personnel in issues related to the current good manufacturing practices in the code of federal regulations. Some places use their error/accident monitoring to select the topic for the next year. Basically anything related to the cGMPs can be used, but you have to identify it as cGMP training when you do it. I had FDA show up one time and ask for this and I showed them all sorts of relevent training, but since none of it was called "cGMP training" I got cited.

Essentially you have to have documentation of competence/training of all personnel in issues related to the current good manufacturing practices in the code of federal regulations. Some places use their error/accident monitoring to select the topic for the next year. Basically anything related to the cGMPs can be used, but you have to identify it as cGMP training when you do it. I had FDA show up one time and ask for this and I showed them all sorts of relevent training, but since none of it was called "cGMP training" I got cited.

Our facility uses Knowledge trak cGMP training for the last 3 years. Our techs claim only 2/3 of the questions can be applied to our current practice. The rest is non applicable. We are not a donor center and I was hoping to initiate another compliance training other than cGMP which offers more relevance to our facility. Any suggestions?