INTRODUCTION
This Consultant is a former U.S. FDA Investigator with 18 years of industry experience inspecting and auditing Clinical Research Investigator Sites, Clinical Research Organizations (CROs), Sponsors, Vendors, Compounding Pharmacies, Blood Banks, and Tissue Banks. As an Independent Consultant, they conduct domestic and international routine, directed (for-cause), qualification, re- qualification, and inspection readiness audits, as well as mock inspections of investigative sites, CROs, Sponsors, vendors, and compounding pharmacies to assess compliance with protocols, investigational plans, Standards Operating Procedures (SOPs), International Conference on Harmonization (ICH) Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), and Good Pharmacovigilance Practice (GVP) and all other applicable regulations.
They develop and update audit plan objectives to ensure adequate site master files, essential regulatory documents, clinical trial oversight, clinical data management, adequate monitoring, vendor oversight, inspection readiness and overall handling of clinical trial and subject safety profiles. They review Trial Master Files (TMFs), including a variety of essential documents (i.e., FDA 1572s, informed consents, financial disclosures) for accuracy and completion. After documenting audit observations in written preliminary summaries, executive summaries, and audit reports, they formulate corrective and preventive action (CAPA) plans designed to effectively resolve audit observations and assess effectiveness.
They also provide training and training materials to compounding pharmacies, Sponsors, CROs, and investigator site personnel on topics such as inspection readiness, FD&C Act, 21 CFR, Compounding Quality Act, ICH GCP Guidelines, Human Research Subjects, Institutional Review Boards (IRBs), inspections and audits, regulatory guidance documents, and current topics in compounding pharmacy and clinical research.
WORK EXPERIENCE
12/2008 – Present
Industry Consultant
Example Engagements:
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Conduct audits to assess compliance of investigative sites with the protocol, CRO/sponsor SOPs, GCP, GLP, ICH, and all applicable regulations.
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Conduct Potential Investigator, Pre-Study (Qualification), Site Initiation, Interim and Close-Out (Final) monitoring visits.
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Develop and update audit plan objectives to ensure adequate TMFs, clinical trial oversight, clinical data management, adequate monitoring, and overall handling of clinical trial safety profiles.
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Coordinate and conduct Clinical Site Audits in accordance with sponsor SOPs, to GCP, ICH Guidelines, and federal, state, and local regulations.
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Qualify selected vendors to ensure outsourced areas meet regulatory standards.
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Complete clinical data trend analyses.
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Document audit observations in written audit reports.
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Follow-up and work closely with individual departments on resolution of audit observations and corrective action plans and report issues to the relevant management for action.
2003 – 2008
U.S. Food and Drug Administration
Investigator/Consumer Safety Officer
Duties:
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Specialized in the inspection of clinical research facilities, blood banks, and tissue banks and who are required to adhere to federal regulations related to the clinical investigators, institutional review boards, protection of human subjects, and informed consent.
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Traveled domestically and internationally to complete complex inspection assignments.
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Monitored blood establishment registration for the New York upstate and downstate area.
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Provided classroom and on-the-job training to fellow FDA employees regarding federal laws and regulations like the Code of Federal Regulation and Food, Drug, and Cosmetic Act.
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Prepared materials for distribution within the agency and for public distribution including training materials, written reports of inspectional observations and establishment inspections, and recommendations for regulatory enforcement.
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Achieved Level I and Level II Investigator certifications.
2001 – 2003
Louisiana Best Clinical Research Organization, Inc.
Clinical Research Associate
Duties:
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Conducted all aspects of monitoring, including initiation, interim and close out visits.
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Managed multiple centers in US and ensured the quality and integrity of clinical trials by performing and coordinating all aspects of clinical monitoring or case report forms, study and source documents for their accuracy and protocol adherence in accordance with GCP/ICH guidelines and global SOPs to assess the safety and efficiency of investigational products.
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Documented all study activities including investigator contacts using relevant forms.
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Assembled, maintained and audited documents in central files in order to accurately reflect the progress of the study and ensure compliance with GCP and internal/Sponsor SOPs.
EDUCATION
2005 – 2007
Nova Southeastern University
Doctor of Health Science: Health Science
2001 – 2003
University of New Orleans
Master of Education: Health Promotion
1995 – 1999
University of New Orleans
Bachelor of Science: Biological Science
ADDITIONAL EXPERIENCE
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Lead consultant assisting a Middle Eastern pharmaceutical client through their first U.S. FDA inspection. They worked closely with the client as well as their vendors and investigator sites in multiple countries to provide training regarding the U.S. FDA inspection process. They also assisted with the development of a quality and risk management plan from both compliance and business perspectives in order to efficiently identify deficient practices and areas for improvement in future clinical trials. U.S. FDA had only minor findings during the inspection.
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Expert consultant assisting a leading California compounding pharmacy prepare for and respond to U.S. FDA inspection findings. They conducted a gap analysis, several on-site audits, and assisted with drafting responses to FDA 483s observations to avoid agency official action (i.e. Warning Letter). As preventive action to deter future violative conditions, They prepared a training program highlighting the Compounding Quality Act requirements and assisted in the revising written procedures to adhere to regulatory requirements and address common deficiencies (e.g. personal protective equipment, environmental monitoring, cleaning and disinfecting, aseptic preparation, testing method procedures) observed during FDA inspections.
AUDITING EXPERIENCE
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[Phase I, II, III, and IV clinical trials), blood banks (FDA Level II Investigator in Blood Banking/Apheresis), tissue banks, and IRBs required to adhere to federal regulations and recommendations related to GMP, ICH GCP, GcLP, regulatory documents, donor screening/testing, donor notification, site qualification, ethics committee, protection of human subjects, case report forms, severe adverse event reports, and informed consent. They also prepared regulatory documents for distribution within the Agency and/or for public administration, including training materials, written reports of inspectional observations and establishment inspections, and recommendations for regulatory enforcement. Moreover, they evaluated written responses from blood banks, tissue banks, IRBs, Principal Investigators, Sponsors and Vendors regarding corrective actions plans to FDA 483s to determine the adequacy of proposed corrections and preventive actions. As a member of the International Inspection Cadre, They served as the Lead Investigator on multiple international inspections.
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Expert consultant conducting audits of domestic and international investigative sites, CROs, Sponsors, and vendors to assess compliance with protocol, SOPs, ICH GCP, GcLP, and all applicable regulations; preparing written preliminary summaries and audit reports regarding audit observations; and ensuring the timely and effective follow up of all identified or assigned quality issues.
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Senior GCP Auditor conducting audits and mock inspections of domestic and international investigative sites, CROs, Sponsors, and vendors to assess compliance with the protocol, SOPs, ICH GCP, GMP, GcLP, and all applicable regulations; preparing written preliminary summaries and audit reports regarding audit observations; ensuring the timely and effective follow up of all identified or assigned quality issues; and reviewing TMFs, including a variety of regulatory documents (e.g. FDA 1572s, informed consents, financial disclosures) for accuracy and completion.
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Quality Assurance Consultant/Senior GCP Auditor conducting audits of domestic investigative sites, CROs, Sponsors, and vendors to assess compliance with the protocol, SOPs, ICH GCP, GMP, GcLP, and all applicable regulations; providing input into QC plans and processes relating to TMF management; reviewed SOPs to ensure procedures and systems used in the conduct of clinical trials are in compliance with applicable guidelines and regulations; assessing vendor qualification, management, and certification programs; and maintaining open and frequent communications with external and internal stakeholders.
CERTIFICATIONS
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Registered Quality Assurance Professional – Good Clinical Practice (RQAP-GCP)
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Certified Clinical Research Professional (CCRP)
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Master Certified Health Education Specialist (MCHES)
TRAININGS
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Prior U.S. FDA Consumer Safety Officer/Investigator providing advanced classroom and on-the-job training to fellow U.S. FDA employees regarding bioresearch monitoring, blood borne pathogens, aseptic sampling, and federal laws and regulations such as the Public Health Safety (PHS) Act, Code of Federal Regulations (CFR), and Food, Drug and Cosmetic (FD&C) Act.
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Quality Assurance Consultant providing training to fellow Consultants and personnel at investigative sites, CROs, Sponsors, and/or vendors
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GMP
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GCP/GDP
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Bloodborne Pathogens
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Mock FDA Inspections
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FDA Inspection Readiness
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Writing Effective CAPA Plans
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Preparing for a FDA Inspection
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Risk-Based Quality Management
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Preparing Written Procedures and Policies
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Hosting a Regulatory Authority Inspection
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Principal Investigator Oversight and Responsibilities
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Common Principal Investigator Pitfalls in Clinical Research
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Common Audit and Inspection Findings at Investigator Sites
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Preparing an Adequate Written Response to a FDA 483, Inspectional Observations