Erin Hyer Krohl

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Education:

B.S. Biochemistry, Louisianna State University, 1984
M.S. Pharmacology, LSU Medical Center, 1986
Masters Public Health, University Alabama-Birmingham, 1990

Applicable Food and Drug Administration (FDA) courses attended:

Computer Systems Validation: Atlanta, GA, April 1995.
LAL and Sterility Tests, QA/QC for Inspecting Laboratories: Atlanta, GA, January 1995.
Industrial Sterilization for Drugs and Devices: Raleigh, NC, July 1992.
Interviewing and Interrogation: Ft. Lauderdale, FL, May 1992.
Blood Bank and Plasma Inspections: Atlanta, GA, October 1990.
Basic Food and Drug Law and Evidence Development: Ft. Collins, CO, July 1990.

Professional Experience:

President, EHKrohl Consulting, Inc. Raleigh, NC
January, 1996 - Present:

Provide advice, expertise, in-house training, project management to the human and veterinary pharmaceutical, medical device, biologics, biotechnology and affiliated industries, with regards to compliance with: FDA Good Manufacturing Practices (GMPs), Quality System Regulations (QSR), Good Laboratory Practices (GLPs), and Good Clinical Practices (GCPs) regulations; Part 11 Electronic Records, Electronic Signatures requirements as well as ICH guidelines.

Facilitate FDA approval of product applications, including performance of mock FDA pre-approval inspection audits; Serve as firm representative to the FDA and participate in on-site FDA inspections.

Determine GXP/QSR compliance, including performance of mock FDA audits; GMP, QSR, GCP, (sponsor, site, PI, CRO - Phases I-IV), and GLP compliance audits; contractor/vendor/CRO audits and assessments. Development and management of corrective action plans to bring firms into compliance

Analysis and development of GMP, GLP, GCP, and Quality Assurance systems.

Focused audits – data, potential fraud, due diligence, etc.

Serve as “cGMP expert auditor” for firms that have received a consent decree. Aiding firms with recall situations. Serve as official Drug monograph expert.

Review of regulatory applications, process validation, computer system validation documentation, stability programs, CMC, etc.

Safety/post-marketing adverse event reporting/ complaint system audits.

Prescription Drug Marketing Act process review.

Preparation of responses to FDA Warning/Untitled letters and FDA- 483 with CAPA approach.

Analysis and development of Standard Operating Procedure systems and documentation.

Conducted GXP audits in Asia/Pacific, Eastern Europe, Japan, India, Middle East, North America, South America, Western Europe

QA Senior Compliance Auditor, Quintiles, Inc., Research Triangle Park, NC
July 1995 - July 1996:

Responsibilities included: Planning and conducting client and contractor GMP and investigator site GCP audits; planning and conducting QA systems audits, including computer system validation review; provide information and training with regards to GCP, GLP, and GMP requirements to colleagues and clients; development of training programs and training of QA auditors; assisted in the development of Standard Operating Procedures; participated in client business development presentations; served as consulting project liason.

FDA Investigator: New Orleans, LA; Raleigh, NC
July 1989 - July 1995:

Developed Extensive knowledge of the regulations, expertise in GCP, GLP, and GMP inspections of both foreign and domestic firms in the bioresearch, pharmaceutical, medical device, and biotech industries, including routine and “for cause” fraud inspections.

Bioresearch: Conducted inspections of both foreign and domestic GLP facilities; bioequivalent facilities; Sponsor/Monitor; CROs; QAUs; IRBs; Contract Clinical Labs, including team inspections with FDA Headquarters scientists and training of other FDA Clinical Investigators; Also proficient in conducting computer systems validations. Performed audits of pharmaceutical NDA, ANDA, IND, non-clinical and device 510(K), PMA clinical trials for the following therapeutic areas: audiology, cardiovascular, general surgery, gynecology, immunology, infectious diseases, nephrology, neurology, oncology, psychiatry, pulmonary, and urology. Selected as the Atlanta District Bioresearch Monitoring Specialist, November 1992.

Pharmaceutical Industry: Inspections of foreign and domestic innovator and generic manufacturers of all dosage forms, including sterile, irradiated, and lyophilized products; NDA and ANDA pre-approval inspections; bulk drug manufacturers; veterinary drugs; inspections of ETO, steam, and irradiator sterilizers; investigational drugs; IQ, OQ, and process validation; pharmaceutical water systems; compliant and DQRS follow-up inspections.

Medical Device Industry: Inspections of foreign and domestic Class I, II, III sterile and non-sterile device manufacturers including in vitro diagnostics, and implantable devices; PMA and 510(K) pre-approval inspections; extensive knowledge of device GMP/QSR, validation, Medical Device Reporting, and ISO 9000 requirements.

Biologics/Biotech Industry: Inspection of plasma fractionator, PLA approval, blood banks, and plasma collection facilities, including team inspections with FDA Headquarters scientists and training other FDA Investigators.

On FDA Foreign travel cadre for bioresearch, human and veterinary drug, device, and biologics inspections.