Profile: Experienced former US FDA Drug Specialist investigator with a demonstrated history of working extensively in the pharmaceuticals industry in the US and multiple other countries including: China, India, Germany, Italy, Austria, Ireland, France, the UK and the Netherlands to name a few. Now putting those skills to work as the owner of her own consulting firm providing insight into the workings of the US FDA through: training, conducting Mock FDA audits, advising on facility set up and layouts and advising on the preparation of responses to FDA-483's.Skilled at auditing a wide variety of manufacturers of: Sterile and non-sterile API's, Sterile and Non-Sterile Finished products, Immediate release, Extended release and Timed release Capsules and Tablets, Good Laboratory Practice (GMP) Labs, Good Laboratory Practice (GLP) Lab facilities, Biologically produced APIs and Finished Products and Medical Device manufacturers. With wide experience evaluating and improving documentation in relation to: Change Control, Deviations, Complaints, Investigations and CAPA as well as laboratory documents, raw data and OOS investigations. Well versed in Pharmaceutical, Biotechnology, and Regulatory Requirements. Strong business development professional with a BS focused in Health Sciences w/ 50 hr Microbiology concentration from East Tennessee State University. Language Expertise: English. Based in United States.
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