ICH E6 R2 states it loud and clear- “the scale, complexity, and cost of clinical trials have increased. Evolutions in technology and risk management processes offer new opportunities to increase efficiency and focus on relevant activities.” Time to revise your audit strategy! Join us as we develop audit plans that address quality in a targeted, efficient, nimble, calculated, risk-based manner. Learn to use technology to circumvent governmental travel advisories, weather hazards, resource limitations (auditors, time, budget), etc. without sacrificing audit goals. Garner the experience and expertise of department heads from Data Management, Clinical Operations, Information Technology, etc. to fulfill technical assessment/ oversight requirements. A wide range of audit types [vendor qualification/ re-assessment (CROs, pharmacovigilance, eCOA vendors, etc.), investigator sites, internal process audits (when the department is off-site), trial master files, GLP, etc.] will be discussed.
Who should attend?
- Quality personnel from sponsor companies, CROs, and vendors
- Regulatory agency representatives with experience and feedback on quality audits Data Managers, Clinical Operations, CRAs, Clinical Scientists, Medical Monitors and other project leaders with ideas on how and what critical to quality data should be reviewed by auditors
- Representatives/ consultants of companies that provide auditing services
- Identify which data is critical to quality using risk-based methodologies
- Select novel methods to access documents and data when hosting/conducting a qualification, vendor, investigator site, or other GCP audit
- Develop more comprehensive and cross functional audit plans for oversight activities of vendors and CROs