Donna Hartzfeld, Ph.D. is a President and Owner at Quality Implementation Services. She possess expertise in fda, validation, medical devices, gmp, quality systems and 36 more skills. Colleagues describe her as "I've been lucky enough to have worked with Donna for almost 20 years. She stands out as an extremely well rounded and capable consultant and without fail, she has exceeded my expectations as well as that of the client. Aside from her depth and breadth of knowledge, technical skills, ability to work independently as well as manage teams, she is always a pleasure to work with." and "Donna and I worked on an important long-term project to remediate a small API manufacturer to full cGMP compliancy from an FDA inspection perspective. Donna is a highly organized, technically competant and knowledgeable lab consultant with excellent communication skills. She is a cooperative team player with both clients and fellow consultants. Donna demonstrates a high degree of quality in her work whether it be technically complex in nature or compliance oriented."