This clinical trial audit training reviews the key elements of quality auditing processes and correlates them to the ICH guidelines and applicable FDA regulations.
Why Should You Attend:
Well designed quality auditing program and effectively executed audits of a clinical trial are critically important to both sponsors and investigator sites. Through auditing, the investigator’s compliance with Good Clinical Practice and ICH guidelines is verified, quality of the data and accuracy of the reports are confirmed, or nonconformities and deficiencies are timely identified. This enables the sponsors to speed up the regulatory review process and decrease the costs of bringing the products to the market, as well as, gives the investigator an opportunity to prepare the site and the trial data and records for the FDA inspection.
This Quality auditing in clinical trial training will include the key elements of quality auditing process, auditing methodology, and reporting techniques. In addition, this session will focus on reviewing recent FDA inspection findings and areas of common deficiencies. It will help you understand how key elements of quality auditing process correlates to ICH guideline and other applicable regulations.
Areas Covered in the Seminar:
- Purpose, objectives, and scope of quality auditing of clinical trials for GCP compliance.
- Auditing vs. monitoring vs. quality control
- Routine vs. for cause
- Types of quality audits.
- Clinical sites
- Phase 1 units
- Databases
- Clinical summary reports
- Audit preparation and methodology.
- Risk-based approach
- Site and sample selection
- Records and document review
- Paper vs. EDC –type studies
- Audit reporting (e.g. deficiency reporting vs. quality assessment).
- FDA inspection findings and areas of common deficiencies.
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in: Pharmaceutical, Biotechnology, Medical Devices, and Research Facilities Conducting Clinical Trials including:
- Managers in clinical development
- Quality assurance managers and auditors
- Investigator’s site management
- Clinical Operations and study conduct staff
- Regulatory Compliance associates and managers
Instructor Profile:
Alexandra Dilis, J.D., RQAPGCP is an accomplished quality assurance, professional with over 14 years of experience in life-science industry. Mrs. Dilis held a number of key in-house QA and compliance leadership position and consulted pharmaceutical, biotech, and medical devise companies in the fields of GCP, GLP, cGMP and 21 CFR Part 11 quality and regulatory compliance. Mrs. Dilis holds bachelors of science degree in business administration from Providence College and juris doctor degree from New England School of Law. She is SQA registered quality assurance professional –GCP and a member of the DC Bar.
