FDA Pre-Approval Inspections

As the Vice President, Pharmaceutical Quality Systems and Validation with Quintiles Consulting, Ms. Fritz directs Quintiles Consulting's Pharmaceutical and Biologic Services groups, responsible for assisting pharmaceutical, biologic, and biotechnology companies in their efforts to meet the regulatory requirements of the FDA. The Quality Systems Pharmaceutical and Biologic Services group consists of former FDA and industry experts in the fields of GMP, QSR, GCP, and GLP compliance assessment and implementation. The Pharmaceutical and Biologic Services group works with clients to develop, coordinate, and manage projects of all sizes. Ms. Fritz provides executive oversight of these projects to assure the achievement of sustainable compliance solutions. In addition, Ms. Fritz’s background and expertise allow her to provide clients in the pharmaceutical, biologic, and biotechnology industries with technical advice to assist them in developing practical quality assurance, manufacturing, and regulatory strategies for compliance with FDA regulations. Her team routinely conducts Mock FDA inspections, FDA preparedness training, GXP training, gap assessments, and technical due diligence audits as part of their offerings. In addition, her team, because of their unique qualifications and experiences, can assist companies with regulatory strategies and assist with developing client corrective action strategy, planning, and implementation.

Prior to joining Quintiles Consulting, Ms. Fritz worked for the FDA as an experienced field investigator specializing in pharmaceutical and biologics inspections. During her tenure at FDA, Ms. Fritz was a Biologics Team Leader. She also has pharmaceutical and biotechnology industry experience including management of quality assurance, compliance, validation and qualification, vendor qualification, internal/external audits, batch record review, product release, investigation of non-conformances, cGMP training, and sterile manufacturing. Ms. Fritz is a certified phlebotomist and medical assistant. In addition, Ms. Fritz has had training in pharmacology, health sciences and computer programming. Ms Fritz has a B.A. in Business Administration.Ms Fritz is also a member of the Parenteral Drug Association, the International Society for Pharmaceutical Engineering, RAPS, OCRA, and FDLI.

Mr. John Godshalk is a former FDA inspector in the Division of Manufacturing and Product Quality, CBER. John currently works for the Biologics Consulting Group as a Senior Consultant. John served as a Senior Review Biochemical Engineer and Lead cGMP inspector in the Division of Manufacturing and Product Quality at CBER, FDA. He contributed to formulation of FDA policy as a member of the committee writing the Guidance Document for the Facilities and Controls for Cellular and Gene Therapy Manufacturing Operations. John has provided advice to industry on regulatory strategies, pharmaceutical product facility design, best practices, and validation approaches that meet FDA licensing requirements. John received his B.S. in chemical engineering from N.C. State University and his M.S.E. in biochemical engineering from Johns Hopkins University

Dr. Marla A. Phillips is a Senior Compliance Consultant with the IHL Consulting Group, Inc. In this position, Dr. Phillips has conducted numerous General GMP and Mock-PAI audits, has written FDA 483/Warning Letter responses, reviewed and assessed Laboratory and Operations technical reports, developed and written complex Quality Agreements, and conducted training on all aspects of Quality Operations.

Prior to joining IHL, Dr. Phillips was the Director of Quality Operations for Merck & Co. Inc. In this capacity, Dr. Phillips directed all site Quality activities, including FDA inspection/interaction activities, manufacturing operations, packaging operations, supplier management, contract service management, site-wide quality training, release laboratory operations, and management of the North American Stability HUB. She worked in technical and quality control/operations positions of increasing responsibility while at Merck, including Supervising, then Managing, the Philadelphia site Quality Control laboratory operations for non-sterile product release and stability testing of a complex mix of products. Her career started within Merck as a Senior Chemist in the Regulatory and Analytical Sciences group, which assessed, developed, validated, and transferred analytical methods used to support new product launches world-wide.

Dr. Phillips received her B.S. in Chemistry from Xavier University, and her Ph.D. in Organic Chemistry from the University of North Carolina - Chapel Hill.