Darrell MarkhamSr. IT Project Manager| Tyler TechnologiesBrentwood, Ca, United States
I work for a medical device company. We have a new set of associates in the QA department. I am in disagreement with their direction for how a "Project Plan" should be developed with regards to meeting design control requirements. I have a well developed project definition document, at least I think it is. I think between my PDD and a good schedule that all of the requirements are properly captured. QA wants to write procedures to tell each department involved in the development process how to write individual project plans and what the plans should contain.....ekk!, to be integrated into "The Project Plan". If you have experience in managing R&D projects under FDA regulations I would love to hear your understanding of the FDA guidelines on design and development planning. How do you manage this requirement? Saving Changes...
