Speaker Profile

Stephanie Cooke

20 years

President/CEO of Cooke Consulting, Inc

Stephanie Cooke is the President/CEO of Cooke Consulting, Inc. Stephanie uses her roughly 20 years of experience to provide global consulting services in various areas of Regulatory Affairs, Quality Assurance and validation for pharmaceutical, biological/biotech products, medical device, combination drug/device and nutraceutical firms. Her broad-based experience includes preparation of regulatory dossiers for human and animal pharmaceutical (chemical entities and biologically-based drugs), biotech products, drug/device combination products and medical devices in all stages of development (INDs, NDAs, BLAs, post-marketing supplements such as CBEs, Prior approval supplements, orphan drug designation and related submissions, 510ks, PMAs and HDEs).

She also has extensive QA and validation experience, successfully hosting many regulatory audits conducted by FDA, ISO and other international regulatory bodies (Irish Medical Board and others), training personnel on hosting audits by global regulatory bodies, as well as establishing auditing programs to qualify contract manufacturers and vendors of raw materials, APIs, etc. and product release experience in manufacturing environments and for companies using contract manufacturers, responsibility for establishing and maintaining Quality systems for all product types, establishing stability programs, as well as preparation/performance of process validation(s), including sterilization validation(s) (EtO, steam, gamma), aseptic processing, qualification of cleanrooms/water systems and manufacturing process validation.

Stephanie has been involved in the development of drugs, including biologics, biotech products and medical devices, from product concept through post-approval maintenance including requirements for submissions for various regions/countries, process validation requirements, etc. and has considerable project management experience.

Ms. Cooke is experienced the development of APIs, drug products (including biological/biotech products and their associated manufacturing processes. In addition, she has had much experience working on CMC sections of the CTD for various countries/regions, establishing required preclinical and clinical testing necessary for regulatory filings, as well as preparing the information for regulatory submissions. Prior to beginning Cooke Consulting, Inc.about 9 years ago, Stephanie worked for Scīele­ Pharma from 2005-2009 as the VP of Regulatory Affairs, Quality Assurance/Validation. She also held various senior RA, QA and validation positions at Merial, Bayer (Visible Genetics), Cryolife, Theragenics and other pharmaceutical, biotech and medical device companies, after beginning in industry as a lab tech and working as a certified as a Microbiologist. She has a BS in Biology and an M.S. in Molecular Genetics and Biochemistry from Georgia State University.

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