Dr. Donna Hartzfeld is an experienced consulting professional who has effectively led many teams in the areas of quality systems development, validation, and warning letter response. I have worked with Donna on multiple past projects in the medical device, OTC, and pharmaceutical industries and I would work with/for her again without reservation. She is a valuable asset to any project requiring technical knowledge, regulatory knowledge or skilled leadership to meet critical task deadlines.
Some of the most challenging areas to maintain compliance to FDA regulations include blood, blood derived products, and blood screening tests, tissue and bone based products, and biologics. QIS provides…Read More