PAREXEL International, Principal Consultant (FDA Regulatory Consultant), Waltham, MA
(Feb 1, 2017 – Current)
Provide regulatory support to all FDA Regulated Industries, utilizing broad technical and regulatory expertise to assist clients in the following areas:
- Project Lead for International team of four (4) Auditors in support of a Fortune 500, Multinational Corporation CAR-T Therapy BLA submission, which included approximately 90 onsite biological product supplier audits, checklist development, onsite training, wrote and delivered 90 audit reports (based on auditor findings) to provide consistent compliance assessment to client. FDA Licensure granted in 2017. Project worth in excess of 900,000 USD.
- Audits & Mock-FDA inspections of all FDA Regulated Industries and in all GxP and QSR environments - Human Tissue, Blood, Plasma, Drug, Bioresearch Monitoring (Clinical Investigators, Sponsors, IRB’s), Dietary Supplement Manufacturers, Devices.
- Use FDA inspection/investigation and compliance/enforcement expertise to support client Due Diligence, QSR, Pre-Approval, Pre-License, Internal investigations, Clinical Site Audits, Sponsors, IRBs, Risk assessment, Gap Analysis, and Regulatory Compliance audits.
- Highly experienced with exceptionally skilled working knowledge of FDA Regulations including
21 CFR Parts 50, 56, 111, 210, 211, 312, 600’s, 812’s, 820’s, 1270, and 1271.
- Provide training on FDA Inspection readiness and interview preparation.
- Assessment of current client compliance status, provide guidance on potential problem areas and recommend corrective action.
- Short and long term regulatory strategy for compliance with FDA regulations, and ongoing, periodic assessment of operations.
- Assist clients with development of procedures to ensure compliance with FDA regulations and expectations.
- Guidance on the preparation of product recall or BPD reporting.
- Represent clients in interactions with FDA, back room management, and assist clients in preparing for FDA regulatory meetings.
- Assist clients with review of, and response to, FDA correspondence.
- Provide in-house training on FDA Regulatory issues and new policy developments.
- Evaluation of FDA-483s and FDA Inspectional findings to evaluate FDA strategy.
- Assist clients with the preparation of FDA-483, Inspectional Observations, and warning letter responses.
- Product labeling review and/or website evaluation for review of structure/function or potential disease claims.
- GMP, GCP, GTP Compliance member of CAR-T Therapy Working Group.
- Provide corrective action recommendations for labeling or website changes.
- Interview PAREXEL consultant applicants for positional relevance and to ascertain knowledge, skills, and abilities.
- Current client base includes:
- Biological drug & Biologics (351 Product) Manufacturers (ex. Stem cell and Cellular Therapy)
- 361 Product Tissue-based Therapy Manufacturers.
- CAR-T Therapy – Licensed and regulatory submission pending
- Drug manufacturers (Traditional and Homeopathic)
- IRB’s
- Clinical Investigators
- IND Sponsors
- Blood & Plasma Centers
- Human Tissue Processers
- Cord Blood Facilities
- Dietary Supplement Manufacturers
- Device Manufacturers
- Own label distributors
- Manufacturers of Combination Products
Biologics Consulting Group, Inc., Senior Consultant (FDA Regulatory Consultant) Alexandria, VA
(Sep 1, 2009 – Dec 30, 2016)
Provide regulatory support to all FDA Regulated Industries, utilizing broad technical and regulatory expertise to assist clients in the following areas:
- Audits & Mock-FDA inspections of all FDA Regulated Industries and all GxP environments - Human Tissue, Blood, Plasma, Drug, Bioresearch Monitoring (Clinical Investigators, Sponsors, IRB’s), Dietary Supplement Manufacturers, Devices.
- Supported Cord Blood BLA Approval Project for non-profit Cord Blood Center. BLA approved 2016.
- Use FDA inspection/investigation and compliance/enforcement expertise to support client Due Diligence, QSR, Pre-Approval, Pre-License, Internal investigations, Clinical Site Audits, Sponsors, IRBs, Risk assessment, Gap Analysis, and Regulatory Compliance audits.
- Highly experienced with exceptionally skilled working knowledge of FDA Regulations including 21 CFR Parts 50, 56, 111, 210, 211, 312, 600’s, 812’s, 820’s, 1270, and 1271.
- Provide training on FDA Inspection preparation.
- Assessment of current client compliance status, provide guidance on potential problem areas and recommend corrective action.
- Short and long term regulatory strategy for compliance with FDA regulations, and ongoing, periodic assessment of operations.
- Assist clients with development of procedures to ensure compliance with FDA regulations and expectations.
- Guidance on the preparation of product recall or BPD reporting.
- Represent clients in interactions with FDA & assist clients in preparing for FDA regulatory meetings.
- Assist clients with review of, and response to, FDA correspondence.
- Provide in-house training on FDA Regulatory issues and new policy developments.
- Evaluation of FDA-483s and FDA Inspectional findings to evaluate FDA strategy.
- Assist clients with the preparation of FDA-483, Inspectional Observations, and warning letter responses.
- Product labeling review and/or website evaluation for review of structure/function or potential disease claims.
- Provide corrective action recommendations for labeling or website changes.
FDA, Office of Regulatory Affairs, Florida District Office, FDA Field Investigator, Level II Inspection Certified (Jun. 1995 – Sept 2009)
- Planned and routinely performed inspections in the areas of blood, plasma, human tissue products, devices, bioresearch monitoring of clinical trials (including IRB’s, clinical investigators, sponsors), drug GMP, and dietary supplement manufacturing operations, to ascertain compliance with applicable Good Manufacturing Practices, Federal Regulations, and the Food, Drug & Cosmetic Act.
- Routinely work with the FDA Center Reviewers, including CBER, CDER, CDRH, CFSAN, CVM, in planning and executing Center-driven for cause inspection assignments.
- Performed high level investigations into unlicensed product distribution, fraudulent products, illegally imported human tissues, product tampering, false claims, and fraudulent practices in clinical trials.
- Post-investigation expert witness in cases prosecuted by the US Attorney General’s Office.
- Routinely developed evidence to support FDA Regulatory Action.
- FDA Level II Certification in Inspections of Biological Products.
- Performed QSR inspections to ascertain compliance with 21 CFR 820’s.
- Managed the FLA-DO Dietary Supplement inspectional program, Internet Surveillance, and Undercover Buy Programs, oversee inspectional assignments and evaluation of firm compliance status with 21 CFR 111.
- Routinely served as Acting Supervisory Consumer Safety Officer.
- Routinely served as a FLA-DO trainer for Biologics and Dietary Supplement programs using On- the-job training or Class lecture for new employees.
- Authored and implemented the FDA written procedure for Internet Surveillance and Undercover Buys, and routinely monitored all Florida District investigations under procedure.
- Presented topics & presentations at numerous FDA sponsored classes and workshops.
FDA, Office of Regulatory Affairs, Florida District Office, FDA Supervisory Investigator (Temporary Assignment & Temporary Promotion)
(Jan 2005 - Apr 2005)
- Planned, prioritized, assigned, and reviewed work of a staff of six (6) Investigators which included inspectional and investigational activities in all regulated program areas including Foods, Drugs, Biologics, and Dietary Supplements.
- Monitored the Florida District Office Inspection plans and worked with Compliance to prioritize follow-up assignments.
- Evaluated the inspectional reports produced by CSOs to determine employee compliance with FDA reporting procedures, and initiated appropriate regulatory action based on inspectional findings.
- Evaluated employee performance using written work or on-site inspectional activities.
- Directed the reorganization of the FLA-DO Investigations Branch.
FDA, Office of Regulatory Affairs, Florida District Office, FDA Supervisory Investigator (Temporary Assignment & Temporary Promotion)
(Jan 2002-Apr 2002)
- Implemented the FLA-DO New Hire Training & Mentoring Program.
- Involved in hiring, interviewing, and selection CSO personnel under the 2002 FDA Counterterrorism Initiative.
- Duties as described in the above supervisory detail listing for 2005.
FDA, CBER, Office of Vaccine Research & Review, Division of Vaccines and Related Products Applications, Consumer Safety Officer/IND Reviewer, Rockville, MD (Feb 1991- May 1995)
- The Regulatory Member of the Vaccines Branch Regulatory Review team, with the responsibility of reviewing all incoming Investigational New Drug Applications (IND’s) and supplements for compliance with 21 CFR 312, and initiation of appropriate regulatory action. The product applications consisted of vaccines, toxins, allergenics, and therapeutic immune sera.
- Determination & assignment of IND status, (hold, proceed, termination).
- Notification to IND Sponsors of required action needed, prior to review by Clinical tea.
- Project Management & development of Biological Information Management Tracking System.
PUBLICATIONS
What to Expect When They’re Inspecting Part I, Holly McNair Scott, 2011
EDUCATION
B.A. Biology/Education, University of Central Florida, Orlando, FL (1990)