The FDA Group's Consultant Finder

042

Written by The FDA Group | Jul 12, 2022 7:19:27 AM

Experience

Industry Consultant Jan 2020 - Present

  • European based Global Independent Consultant working to ensure data integrity and patient/subject safety are not over-looked 
  • Conducting Mock Inspections (independently & in conjunction with inspectional teams)
  • Conducting GCP Audits
  • Conducting GAP Analyses 
  • Providing clients with knowledge of the intricacies and complexities of regulatory matters 
  • Ensuring regulatory compliance with Good Clinical Practices, ICH, FDA, EMA, and ISO regulations, guidance, standards and local regulatory requirements
  • Assisting with solutions to inherent challenges and providing assurance of compliance with current regulations
  • Training of personnel responsible for performing duties within the scope of Good Clinical Practices

 

Bioresearch Monitoring Specialist Jun 2013 - Jan 2020

FDA 6 years 8 months

Responsibilities included, but were not limited to: 

  • Conducted more than one hundred GCP audits of Clinical Investigator sites and Ethics Committees
  • Led teams of inspectors on numerous inspections of Contract Research Organizations, Sponsors, and Bioclinical Research Facilities
  • Determined sites compliance with their respective regulations and assisted in determining the actions taken by FDA
  • Assisted in determining whether firm's corrective actions were adequate in respect to the violative findings
  • Performed joint inspections/audits with foreign regulatory agencies (i.e. EMA, MOH, AIFA, etc.) enforcing both ICH and FDA regulations
  • Determined whether inspectional findings warranted a form FDA-483, Inspectional Observations, and whether the impact of the 483 would result in potential regulatory actions
  • Spoke at presentations to groups within FDA and to industry organizations relating to FDA and ICH principles
  • Trained and Mentored newly hired FDA Bioresearch Monitoring (BIMO) Investigators
  • Assisted in the development of BIMO Certification Exams and workshops
  • Received numerous awards over years of work for my personal conduct and achievements relating to FDA's BIMO program area

Specialties

Regulatory Affairs; Clinical Research Management and a thorough knowledge of the following regulations along with their associated FDA Guidance documents: 21 CFR Part 11 (Electronic Records), 21 CFR Part 312 (IND);

21 CFR Part 314 (NDA); 21 CFR Part 320 (ANDA); 21 CFR Part 812 (IDE); 21 CFR Part 514 (NADA); Part 50

(Protection of Human Subjects), & 21 CFR Part 56 (Institutional Review Boards)

 

Investigator - Consumer Safety Officer Aug 2008 - Jun 2013

FDA 4 years 11 months

Responsibilities included, but were not limited to: 

 

  • Conducted more than one hundred GCP, GMP, Dietary Supplement inspections of firms manufacturing/distributing those respective products
  • Led teams of inspectors on numerous Bioresearch Monitoring (BIMO) inspections, GMP Inspections, Biological Product Inspections, and Dietary Supplement Manufacturing inspections
  • Determined firm's compliance with their respective regulations and assisted in determining the actions taken by FDA
  • Assisted in determining whether firm's corrective actions were adequate in respect to the violative findings
  • Trained and Mentored newly hired FDA Consumer Safety Officers
  • Assisted in the development of new hire trainings, presentations, workshops, and exercises
  • Received numerous awards over years of work for my personal conduct and achievements across multiple commodities

 

Specialties

Regulatory Affairs; Clinical Research Management; 21 CFR: Part 11 (Electronic Records), Part 111 (Dietary

Supplement cGMPs), Part 210/211 (Drug cGMPs), Part 312 (IND), Part 314 (NDA), Part 320 (ANDA), Part 812

(IDE) Part 514 (NADA), Part 600/601/610 (HCT/Ps), Part 606/640 (Blood & Blood Products)




Education

Florida Atlantic University

BS, Biology

Languages

English (Primary)

Skills

Good Clinical Practice (GCP)   •   Regulatory Affairs   •   Project Management   •  Information Technology   •   U.S. Food and Drug Administration (FDA)   •   FDA GMP   •   Electronic Data Capture (EDC)   •   ICH  •   Microsoft Office, Adobe, additional word processing software and database management software •  Strong written and oral communication abilities 

 

Certifications

Certified Bioresearch Monitoring Investigator • FDA Oct 2019 - Oct 2022