Sherry Dunn work email
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Sherry Dunn personal email
Forward-thinking, Self-motivated, driven. I am a driven, self-motivated, and forward-thinking professional with 15 years practical experience in research, regulatory, and industry. Additionally, I am an accomplished team leader. I achieved Level 1 Certified FDA Consumer Safety Officer (Investigator), Lead Auditor Certification with Safe Quality Food Institute (SQF) and ISO 17025 lead auditor. I am qualified to audit across a wide range of facilities: food, drug, device, clinical, and biological. As part of routine audits, I have reviewed various quality systems, determined whether those systems met federal regulatory standards, and whether the systems were carried out as required by the company’s protocol. As an FDA investigator, I worked closely with other federal regulatory authorities, as well as state, local entities, and industry to ensure regulatory compliance. I attended regular meetings between the Centers for Food Safety, FDA and state counterparts to discuss inspectional coordination between federal and state entities for industry. As a contract regulatory auditor, I worked to provide direction and guidance to my team, ensuring we worked cohesively and effectively. I also made sure our mission was clear and sustained throughout the audit. As a Contract Research Organization (CRO) senior auditor, I regularly hosted sponsor, third party, and regulatory audits in both domestic and international settings. I ensured the capture of any deficiencies resulted in a corrective action and followed through to a successful completion and with preventive action processes put in place. I conducted audits globally to assess GxP conditions in a wide range of pharmaceutical entities including third party/supplier qualifications and certifications.I am accustomed to working remotely out of Atlanta, Georgia, and traveling approximately 50 percent of the time.
Natural Born Consultants Llc
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Principal ConsultantNatural Born Consultants Llc Nov 2020 - PresentFormer FDA Investigator – Level 1Food/Dietary Supplements, Biotech, Pharma, Device, ClinicalCannabis Quality/Safety Systems from grower to retailerQuality, compliance, and regulatory guidance Risk analysis – risk management plans Food Safety TrainingHACCP, Food Safety and Food Defense Environmental evaluations/plansRecall & Traceability planning/trainingSanitation program evaluations/plansAudits/Audit prep – site, facility, supplier, systems, safety/PharmacovigilanceCrafting regulatory responses
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ConsultantConsulting Jan 2019 - Present
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Senior Quality Assurance AuditorPharm-Olam International 2017 - 2019Houston, Tx, Us -
InvestigatorFda 2010 - 2017Silver Spring, Md, Us•Investigation of complaints of injury, illness, or death caused by an FDA-regulated product •Initiating actions against violators •Conduct investigations/audits of facilities where food is produced•Issue all forms required to conduct inspections, keeping regulatory notes •Interact and coordinating with state and other federal agencies•Finished goods sampling, collecting environmental samples, and/or aseptic samples as required by the investigation•Present the observational findings at the end of an inspection •Reading and interpreting protocols and records (supplier certifications, sops ssops) pertaining to facility operations •Writing reports pertaining to investigations (EIRs, Memos collection reports and Affidavits)•Using guidance from Compliance Programs, the IOM, and the FD&C Act to facilitate investigations•Issue all official inspection forms (FDA 483, 484, 461a, 482)
Sherry Dunn Skills
Sherry Dunn Education Details
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The University Of GeorgiaFood Science And Technology
Frequently Asked Questions about Sherry Dunn
What company does Sherry Dunn work for?
Sherry Dunn works for Natural Born Consultants Llc
What is Sherry Dunn's role at the current company?
Sherry Dunn's current role is Principal Consultant at Natural Born Consultants LLC.
What is Sherry Dunn's email address?
Sherry Dunn's email address is sh****@****fda.gov
What schools did Sherry Dunn attend?
Sherry Dunn attended The University Of Georgia.
What skills is Sherry Dunn known for?
Sherry Dunn has skills like Photoshop, Html, Strategic Planning, Budgets, Editing, C++, C, Java, Data Analysis, Analysis, Government, Policy.
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