Industry Consultant

AREAS OF EXPERTISE

  • Creating/editing/reviewing SOP's and required regulatory documents
  • Conducting/reviewing validations including process, cleaning and method
  • Reviewing design controls ensuring necessary requirements have been considered and properly documented
  • Training of key personnel on updates or other changes to the Quality System
  • Table Egg inspections/investigations
  • A firm understanding of the FD&C Act and the 21 Code of Federal Regulations
  • Conduct thorough and complete audits both independently and as a team member
  • Complete reports and training in a timely manner
  • Ability to maintain control to ensure audits continue to move forward
  • Capable of working as a team member or independently
  • Conducting 483 and warning letter responses and warning letter mitigation.
  • Experience in auditing, recognizing and correcting gaps in Outsourcing Pharmacies
  • Formal training and extensive Inspectional experience in CAPA Investigations including Complaints, OOS, Non Conformance and Deviations.

INTRODUCTION

They received FDA training in Drugs and Medical Devices including Industrial Sterilization, IVD's and Process Validation; Foods; Tissue Residues; Table Eggs; Biologics including Plasma Manufacturers; Donor Blood and Hospital Blood Banks and Tissue Manufacturers.  

They were on the initial Table Egg investigation team which began environmental sampling training and is comfortable and knowledgeable in sampling locations; sample types; sampling equipment, determining routes of contamination prior to sampling and communication with the requested testing laboratory before and after samples have been collected.  As lead investigator in Table Egg inspections/investigations, they have trained other investigators on all of the above.  This is becoming an important element in current Food Manufacturing.    

Although formal training is important, her best training experiences have been conducting independent inspections/investigations relying on my problem solving skills and regulation interpretation to provide an accurate determination of compliance or concerns.

They have formal education, training and years of experience in the Medical Laboratory which enhances her skills to conduct audits independently.

Additional areas of expertise in includes ensuring all logistics of both Auditors and Firm Management to ensure continuity and prompt comprehensive audit conclusion.  Ability to conduct audits in multiple program areas.  Solid knowledge and comprehension of the Food, Drug and Cosmetic Act and the 21 Code of Federal Regulations.  Substantial experience in evidence development resulting in Warning Letters and Regulatory Meetings following independent inspections/investigations in program areas such as Medical Devices including Orthotics and Prosthetic's, Drugs including OTC, Tissue Residues and Medicated Feed manufactures.  They received 2 Warning Letters from 1 investigation following a Tissue Residue inspection, as they followed the drug to the feed manufacturer.  Her last 2 inspections (Medical Devices) with FDA resulted in 1 warning letter and 1 regulatory meeting.

 

WORK EXPERIENCE

06/2014 – Present

Industry Consultant

01/2009 – 06/2014 

FDA Des Moines, Iowa Resident Post

Investigator

04/2007 – 11/2008 

OTC Drug Firm, Iowa 

Quality Manager

Prior work history includes employment at various hospitals from December 1985.  

 

EDUCATION

12/1985

DMAAC, Ankeny, Iowa

Associate of Science  

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