Stephanie CookePresident, Vice President | Oklahoma City, Oklahoma
Stephanie Cooke is the President of Cooke Consulting, Inc., using her 20 years of experience to provide global consulting services in various areas of Regulatory Affairs, Quality Assurance and validation for pharmaceutical, bio pharmaceutical, medical device and nutraceutical firms. Her broad-based experience includes preparation of regulatory dossiers for human and animal pharmaceutical and biotech products, drug/device combination products and medical devices in all stages of development (INDs, NDAs, post-marketing, orphan drug submissions, 510ks, PMAs and HDEs).
She also has extensive QA and validation experience, hosting many compliance audits conducted by FDA, ISO and other international regulatory bodies,management of auditing program to qualify contract manufacturers and vendors of raw materials, APIs, product release experience in manufacturing environments and for companies using contract manufacturers, responsibility for QMS for all product types (CAPA, Complaint, Document Control systems), stability programs, as well as performance of manufacturing process validation, sterilization validation (EtO, steam, gamma), aseptic processing, qualification of water systems and qualification of equipment.
Conference Session Materials
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