GLEN FEYE
PRINCIPAL CONSULTANT

Lead Project manager. Able to guide a firm; in preparation of product develop-ment and a FDA inspection, responding to FD-483, initiating and implementing a Corrective Action Master Plan. Implemented strategic corporate quality systems, which complied with the appropriate US FDA regulations and requirements.

Excellent communication skills. Presenter and lecturer at several FDA/Industry conferences and seminars.

Lead Assessor and performance auditor in all areas of medical devices, biologics, and pharmaceutical regulations.

WORK EXPERIENCE:

1999-Present Accurate Consultants, Inc., San Diego CA, President

Principal consultant to the FDA regulated industries specializing in regulatory gap analysis and resolving identified Quality Assurance and Quality Control deficiencies; implemented Quality Systems for medical device, biologic and pharmaceutical firms

Emphasis on preparation for Pre Approval Inspections (PAI), corrective action master plans, and continuous improvement programs

Works with clients in the FDA regulated industries to develop quality assurance, manufacturing, and regulatory strategies for compliance with FDA regulations by:

• Conducting assessments of client studies, procedures, and programs to determine compliance
  
• Assisting with development and implementation of quality systems
  
• Developing and implementing corrective action plans to address deficiencies
  

Projects have included:

Third party Quality System Regulation and GMP auditor


Responded to 483 observations and submitted responses to the FDA. Generate strategic corrective action master plans correct deficiencies so the firm’s meet regulatory commitments.


Served as interim Director of Quality Assurance and Quality Control


Project leader for the preparation of PAI


Developed and implemented Quality Systems procedures


Developed and implemented Product Recall Strategies

PROFESSIONAL AFFILIATIONS:

American Society for Quality (ASQ)

Parenteral Drug Association (PDA)

San Diego Regulatory Affairs Network (SDRAN)

Regulatory Affairs Professional Society (RAPS)

PRESENTATIONS:

“Best Practices for cGMP Audits, PAI, and Corrective Action Plans”, Instructor for International Quality and Productivity Center-Center for Pharmaceutical Training: Chicago, IL. (Nov 18-19,2002), Princeton, NJ. (Dec 16-17, 2002), San Francisco, CA. (Jan 30 –31, 2003), Philadelphia, PA. (Feb 24 –25, 2003), Philadelphia, PA (April 28-29, 2003), Chicago, IL. (June 23-24, 2003), San Francisco, CA (July 28-29, 2003).

Laboratory Compliance Seminar Series:“ Pre-Approval Inspections: Before, During, and After”, Institute of Validation Technology –San Diego, CA, October 12, 2001.

PAI 2001- Meeting Chair. “ Executing a Successful Re-Inspection Strategy Following an Unsuccessful PAI-Interactive.” Barnett International -Philadelphia PA, June 11-12, 2001.

Avoiding a Warning Letter, How to effectively prevent a 483. “ Executing a Successful Re-Inspection Strategy Following an Unsuccessful FDA Inspection-Interactive Session.” Institute of International Research- Philadelphia PA, September 18-19, 2000.

PAI 2000.:“ Executing a Successful Re-Inspection Strategy Following an Unsuccessful PAI-Interactive.” Barnett International -Philadelphia PA, June 11-12, 2000.

Avoiding a 483. “ Executing a Successful Re-Inspection Strategy Following an Unsuccessful FDA Inspection-Interactive Session.” Institute of International Research-San Diego, CA, November 4-5, 1999.

Pre-Approval Inspections:“ Executing a Successful Re-Inspection Strategy Following an Unsuccessful PAI.” And “Ask the Experts-Panel Discussion”. Barnett International -Philadelphia PA, June 17-18, 1999.

EDUCATION:

1994 American Society of Quality Control, ASQC Certified Quality Engineer

1982 Master of Science in Pathology, University of Mississippi, Jackson, MS

1980 Bachelor Degree in Biology, Gettysburg College, Gettysburg, PA