Erin Hyer Krohl
President, EHKrohl Consulting, Inc.: Raleigh / Durham, NCJanuary, 1996 - Present:
Provide advice, expertise, in-house training, project management to the human/veterinary API and finished pharmaceutical manufacturers, medical device, biologics, biotechnology, and affiliated industries worldwide. Audit and assess GXP industries for compliance with: FDA Good Manufacturing Practices (GMPs), Quality System Regulations (QSR), Good Laboratory Practices (GLPs), Good Clinical Practice (GCP) regulations; Part 11 Electronic Records, Electronic Signatures requirements; Postmarketing Adverse Drug reporting (PADE) and Risk Evaluation and Mitigation Strategies (REMS) reporting, Safety Reporting for INDs and BA/BE, Good Pharmacovigilance practices (GVP); as well as associated ICH and ISO guidelines.
- Facilitate FDA approval of product applications, including performance of mock FDA GXP pre-approval inspection audits, serve as firm representative and participate in on-site FDA and Health Canada inspections.
- Conduct mock-EMA GCP and GVP audits.
- Determine GXP/QSR compliance, including performance of routine and mock audits, GMP, QSR and ISO 13485, GCP (sponsor, site, PI, CRO - Phases I-IV), GLP compliance audits, contractor/vendor/CRO audits and assessments, and pharmacovigilance/post-marketing adverse event reporting/ complaint system audits, as well as call center audits.
- Audits of analytical/bioanalytical laboratories, bioequivalence/pharmacokinetic studies.
- Focused audits – data, potential fraud, due diligence, etc.
- Prescription Drug Marketing Act process review.
- Analysis and development of GMP, GLP, GCP, GVP, and Quality Assurance systems and processes.
- Audits and analysis of GXP computer systems for compliance with 21 CFR Part 11 requirements.
- Serve as “cGMP expert auditor” for firms that have received a consent decree.
- Review of regulatory applications, process validation, computer system validation documentation, stability programs, CMC, etc.
- Preparation of responses to FDA Warning/Untitled letters and FDA- 483 with CAPA approach.
- Analysis and development of Standard Operating Procedure systems and documentation.
- GXP audits in Asia/Pacific, China, Japan, India, Middle East, North America, South America, and Europe
- Development and management of corrective action plans to bring firms into compliance.
QA Senior Compliance Auditor, Quintiles, Inc.: Research Triangle Park, NCJuly 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, NCJuly 1989 - July 1995:
Developed extensive knowledge of the FDA regulations, as well as expertise in GCP, GLP, and GMP inspections, foreign and domestic, in the bioresearch, pharmaceutical, medical device, and biotech industries, including routine and “for cause”/fraud inspections. On FDA Foreign travel cadre for bioresearch, human and veterinary drug, device, and biologics inspections. Biologics/Biotech industry: inspection of plasma fractionator, PLA approval inspections, blood banks and plasma collection facilities, including team inspections with FDA Headquarters scientists and training of other FDA Investigators.
Bioresearch: Conducted inspections of foreign and domestic GLP facilities; bioequivalence/bioanalytical facilities; Clinical Investigators; IRBs; Sponsor/Monitor; CROs; QAUs; Contract Clinical Laboratories, including team inspections with FDA Headquarters scientists and training other FDA Investigators. Also proficient at conducting inspections of computer systems - completed FDA Training course “Computer System Validation”. Audited pharmaceutical NDA, ANDA, IND, non-clinical and device 510(K), PMA clinical trials in 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. Medical Device industry: inspections of domestic and foreign 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 9000/13485 requirements. 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; Inspections of bulk drug, veterinary drugs, investigational drugs manufacturers. Inspections of ETO, steam, and irradiator sterilizers; Review of IQ, OQ and process validation, pharmaceutical water systems; complaint and DQRS follow-up inspections.