This rigorous four-day program is ideal for those who are looking for an in-depth, hands-on introduction to conducting laboratory audits. Participants will come away with a basic understanding of audit principles and process with audit planning, conduct, report preparing, and closeout. Portions of the course will be hands-on in the lab where we review various laboratory equipment and documentation to simulate an actual lab audit. Attendees will work through each step of the audit process as a team. The risk-based approach to auditing will be discussed as well as key highlights surrounding regulatory inspection preparedness. This workshop is ideal for lab staff, QC, QA, and other operations staff interested in moving into or responsible for auditing.
Lecture and Hands-on Interactive Training
Team taught by active researchers
Thumbnail drive with Lectures and Workshop material
Space limited to 18 participants
Registration Fee: $995
Dr. Susan Leister
Vice-President of Quality and Compliance
Technical Resources International Inc.
- Background of Auditing.
- Routine vs. For Cause Audits.
- Auditing Strategies/Techniques (why audit).
- Preparation for Auditing a Lab.
- Preparing a Lab Audit Plan.
- Preparing a Lab Audit Checklist.
- Simulating the Opening Meeting of a Lab Audit.
- Conducting Interviews in a Lab Audit.
- How to Review Objective Evidence and What to Look For.
- Simulating the Closing Meeting for a Lab Audit.
- Preparing a Lab Audit Report.
- Finding vs Recommendations, What is the Difference.
- Resolution of Audit Findings.
- How to Close Out an Audit.
- When to Reaudit?
Dr. Susan Leister
Dr. Susan Leister serves as the Vice-President of Quality and Compliance at Technical Resources International Inc. and faculty for the University of Phoenix in both graduate and undergraduate studies with over 20 years of experience in the pharmaceutical, biotech, and medical device industry. She has a Bachelor’s degree in Biochemistry and Molecular Biology, an MBA, a Doctorate Degree in Organization & Management with a focus in Leadership and holds certifications from ASQ as a Certified Quality Auditor and a Six Sigma Black Belt. She has led numerous regulatory inspections and built several quality management systems from the ground up. In addition, she has obtained CE marking for medical devices and helped organizations become ISO certified. Dr. Leister recently received three Merit Awards from the National Institute of Allergy and Infectious Disease. Dr. Leister is a seasoned speaker covering global platforms on a variety of topics from quality risk management, quality tools, and inspection readiness.
Dr. Shelia Russell McCullers
Dr. Shelia Russell McCullers is a Quality Assurance Manager with 30 years of scientific experience including quality assurance, regulatory compliance, clinical research, laboratory research, biotechnology quality control, safety monitoring, biomedical diagnostic testing, training, and auditing. She has conducted multiple audits and hosted several successful inspections including internal inspections, EMA, CLIA and FDA. As an auditor, she is well-versed in audit preparation, execution and reviewing post-audit proposed corrective and preventative actions. As an auditee, she is proficient in preparing staff for audits and inspections to ensure compliance with applicable state, federal and company procedures/regulations. She has conducted trainings related to auditing via webinars and in person within government and private sector settings. While serving in the military, she conducted laboratory research with a focus of toxins that were potential biological weapons. As a civilian, she has worked in multiple laboratories with a focus on sepsis, adult respiratory distress syndrome, chronic congestive heart failure and a myriad of infectious diseases. Dr. McCullers has completed training in quality assurance, GMP, GLP, GDP and GCP. She holds a Bachelor’s degree in biology, Master of Science degree in Biotechnology Management, and a Doctor of Management degree in Organizational Leadership