Eric Cooke Email & Phone Number

Consultant with over twenty years experience in the drug, biotech and medical device industries covering Quality Engineering, Validation, QA Validation, Commissioning/Qualification, Computer System Validation, eCompliance and Engineering for privately held/multinational corporations and Architectural/Engineering firm. Expertise with combination products and sterile / non-sterile products produced via axenic, aseptic, and/or clean manufacturing processes, as well as facilities, utilities, equipment, computer systems and processes used in the manufacturing process. Knowledge of US and EU cGMP’s, ISO requirements and current guidance documents. Experience with greenfield projects and major facility upgrades, design/build process. Experience with Engineering and Quality Systems used from project phase through operation. Project Management and supervisory experience. Served on many design, project and technical transfer teams. Provided input and documentation to support regulatory submissions of new or changed products. Experience in internal and external auditing of vendors for regulatory compliance determination. Extensive Validation Master Plan, Validation Plan, and protocol/final report writing. Statistical analysis/analysis of data expertise.

Listed skills include Validation, Quality System, Quality Assurance, Fda, and 21 others.

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  State University Of New York At Plattsburgh

  Physics