Medpace will be participating in one of the sessions during the conference. Michael Baptist, Medpace’s Associate Director of Quality Assurance will be presenting on the role of technology in audits.
Session 3: GCP QMS beyond QA compliance
The Role of Technology in Audits – November 7, 2019 | 2:30PM
Organizations have to demonstrate oversight of the contractual obligations they transfer irrespective of which industry (GMP, GLP or GCP). A key tool that has been employed to demonstrate this oversight has been audits especially with the requirements by the regulatory agencies. Most organizations are realizing that these audits are costing more as they continue to increase their global footprint and continue to demonstrate their oversight. In the pharmaceutical space; many companies have a brilliant concept; a blockbuster drug (compound) but are virtual in operation but still they need to demonstrate their oversight. The average cost of running an audit program for most sponsors on a pivotal trial is ~$125,000 and includes but not limited to travel (flight and transportation), accommodations and other ancillary activities. Many trial activities are managed more electronically and as such should be accessible from any location (trial master file, electronic clinical database, safety database and other repositories of data. As such; leveraging off tools that can provide access and enable the evaluation of processes and the remote interview of subject matter experts. This presentation will provide an insight to the potential benefits of remote audits leveraging off technological advancements.
- Audits – what are they and current trends in the industry
- Different types – vendor, site, eTMF, safety
- Oversight by sponsors – ICH E6 R2, internal QMS
- Checks and balances for internal compliance
- Inspection readiness
- Risk-based approach
- The escalating cost of audits and exertion on both internal/external resources/assets
- Leveraging technology and data analytics as tools to streamline cost and maximize efficiency – Information analytics and computer tools
- Remote audits – WebEx, FTP sites, video conferencing
- Virtual tours – google glass
- Mentoring using technology for training auditors and auditees
- A shift from conventional paradigm to a more efficient and seamless process
The conference will be a great opportunity for networking with like-minded colleagues – from breaks and interactive sessions, to QA clinics and drinks receptions, there will be ample opportunity to catch up with previous acquaintances and make new ones. We would love to connect with you.