Speaker Profile
Stephanie Cooke
President/CEO, 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 (CAPA, Change Control, Complaint handling, Document Control systems), stability programs, as well as preparation/performance of process validation(s), sterilization validation(s) (EtO, steam, gamma), aseptic processing, qualification of cleanrooms/water systems, stability testing, impurities testing, analytical testing and qualification of equipment. 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 in the formulation and involved in the manufacturing process of APIs and drug products for drug and biotech products, working on CMC sections of the CTD for various countries/regions, and writing CMC sections and establishing required preclinical and clinical testing necessary. Stephanie worked for Sciele Pharma from 2005-2009 and was VP of Regulatory Affairs, Quality Assurance/Validation for Sciele, prior to leaving in 2009 to start Cooke Consulting. 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.
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 (CAPA, Change Control, Complaint handling, Document Control systems), stability programs, as well as preparation/performance of process validation(s), sterilization validation(s) (EtO, steam, gamma), aseptic processing, qualification of cleanrooms/water systems, stability testing, impurities testing, analytical testing and qualification of equipment. 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 in the formulation and involved in the manufacturing process of APIs and drug products for drug and biotech products, working on CMC sections of the CTD for various countries/regions, and writing CMC sections and establishing required preclinical and clinical testing necessary. Stephanie worked for Sciele Pharma from 2005-2009 and was VP of Regulatory Affairs, Quality Assurance/Validation for Sciele, prior to leaving in 2009 to start Cooke Consulting. 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.