Independent Consultant with over 17 years of auditing experience. Extensive training and medical experience during a 20 year military career is the foundation for providing sound value added auditing. Expertise in a wide range of disciplines, including quality assurance, quality control and pharmaceutical training. Skilled in conducting qualification site audits, investigator site audits, laboratory audits, vendor assessments and facility audits. Experienced in establishing clinical quality assurance units, including development of SOPs and standardized reporting tools. Working knowledge of clinical trial processes, EMA, EU Directives, ICH guidelines, and FDA regulations. CAP LLC provides a wide range of Quality Assurance services to the pharmaceutical and biotechnology industries.Key areas of focus:• Investigator site and vendor audits globally• Developing and writing standard operating procedures (SOPs)• Submission documents and tables listing and graph (TLG) audits• Pre-inspection visits/training in preparation for a regulatory inspection• Computer System Validation (CSV) • Database auditing• Part 11 Compliance auditing• Pharmacovigilance auditing• Trial Master File auditing• GCP and specialized training• GLP/GCLP Laboratory audits• QA support/consultancy• Medical Device auditing experience• Risk Management• Trainer in the areas of: Good Clinical Practices, Good Documentation Practices, Auditing Techniques and any topics related to Quality Assurance

Responsible for collaboratively managing the company and solely responsible for good clinical practice (GCP) quality assurance division of the company. The duties involve prospecting new customer sales and delivery of awarded projects. Responsible for conducting GCP investigator site audits, vendor qualification audits, to include full-service CROs and specialty vendors such data management, Statistics, E CRF vendor, Trial master file audits and other contract services used in a clinical trial. Over 10 years of International auditing experience

Independent Consultant with over 10 years of auditing experience. Extensive training and medical experience during a 20 year military career is the foundation for providing sound value added auditing. Expertise in a wide range of disciplines, including quality assurance, quality control and pharmaceutical training. Skilled in conducting qualification site audits, investigator site audits, vendor assessments and facility audits. Experienced in establishing clinical quality assurance units, including development of SOPs and standardized reporting tools. Working knowledge of clinical trial processes, EMA, EU Directives, ICH guidelines, and FDA regulations. Owner and Consultant at GxP Consulting providing a wide range of Quality Assurance services to the pharmaceutical and biotechnology industries.Key areas of focus:• Investigator site and vendor audits globally• Developing and writing standard operating procedures (SOPs)• Submission document and tables listing and graph (TLG) audits• Pre-inspection visits/training in preparation for a regulatory inspection• Systems and database auditing• Trial Master File auditing• GCP and specialized training• QA support/consultancy• Medical Device auditing experience• Risk Management• Trainer in the areas of: Good Clinical Practices, Good Documentation Practices, Auditing Techniques and any topics related to Quality Assurance

Oversees Qualitity Assurance of Clinical and Bioanalytical activities at PRACs Institute. Provides daily QA oversight for 3 clinical and 2 bioanalytical facilities in North America

management and oversight of 5 clinical research sites in US and Canada.

Global auditor and project management. Audited GCP/GLP facilities world wide. Experience in clinical investigator site audits, CRO qualification audits, clinical and bioanalytical lab audits.

Clinical Quality Assurance Auditor

internal auditing of clinical research studies. assured ICH GCP compliance for all trials.

20 year career in medical field retired AF disabled veteran