The GCP Inspection Readiness Conference of the Year is Coming Back for its 3rd Edition!
Achieve confidence that your company is GCP inspection ready by walking through every step of the inspection preparation and execution process. Leave having heard directly rom the regulators themselves about inspection trends, what you need to implement to ensure you are prepared, and understand how technology and effective training can be utilized to drive a culture of quality, and a continued state of GCP inspection readiness.
The highly expected GCP Inspection Readiness Conference in 2023, unfolded as a resounding success, leaving attendees enriched with invaluable insights into GCP inspection readiness. Participants immersed themselves in engaging workshops and interactive discussions, gaining profound knowledge from industry leaders who shared their expertise on critical thinking organization, ICH E6(R3), and navigating risks beyond the TMF.
FDA REPRESENTATIVES AND LEADERS FROM THESE COMPANIES HAVE ATTENDED THE SUMMIT IN THE PAST
Top Reasons to Attend
Understand the impact of ICH E6(R3) on GCP inspections and how to prepare
Assess Critical to Quality factors to establish the building blocks for your GCP inspection readiness plan
Ensure you are executing a proportionate risk-based approach to inspection preparation and readiness
Leverage available tools such as audits, mock inspections, training, even your TMF, to assess and mitigate risk and ensure inspection readiness
Outline the sequence of events for an actual inspection to ensure a comprehensive understanding of the stakeholders who should be involved and roles required
Discuss quality culture as the heart of any successful inspection readiness plan
DISCOVER WHAT OUR LAST YEAR’S ATTENDEES ARE SAYING ABOUT THE EVENT!
2023 Speaking
Faculty
Stefan van den Akker
ACADIA PHARMACEUTICALS
Leah Andrews
ANDREWS CONSULTANTS; Former FDA Investigator
Donna Dorozinsky
JUST IN TIME GCP
Jennifer Fiorenza
ACADIA PHARMACEUTICALS
Tony Johnson
MALLINCKRODT PHARMACEUTICALS
Rich Marino
EIKON THERAPEUTICS
Cheryl McCarthy, RQAP-GCP, CQA, CMDA
Dawn Niccum
INSEPTION GROUP
Karin Rezzonico, RQAP-GCP
INSEPTION GROUP
Kevin Richards
ASTRAZENECA
Leslie Sam
LESLIE SAM AND ASSOCIATES, LLC
Niloy N. Shah
HUTCHMED
John Sikora
HALLORAN CONSULTING GROUP
Jennifer Stamper
JUST IN TIME GCP
Michael Torok, Ph.D.
GENENTECH, A MEMBER OF THE ROCHE GROUP
2024 SPONSORSHIP OPPORTUNITIES ARE OPEN
top-level decision-makers, innovators, and industry disruptors. There are a number of ways to maximize branding opportunities at the summit.
WHO SHOULD ATTEND
This event is developed for professionals from pharmaceutical, biotechnology and medical device companies, CROs, clinical service and technology providers as well as those professionals from sites who have responsibilities in any the following areas:
- Inspection/ Inspection Readiness
- Compliance/ Clinical Compliance/ Regulatory Compliance
- Auditing
- Quality Management/ Clinical Quality Management
○ Clinical Quality Assurance/ QA/ CQA
○ Clinical Quality Control/ QC/ CQC - Quality Operations/ Quality Systems/ Quality Processes
- Regulatory Affairs
- Clinical Operations/ Management/ Research/ Development
- Clinical Outsourcing/ Vendor Oversight and Management/ Strategic Partnerships/ Third-Party Management and Oversight
- Clinical Risk/ Quality Risk/ Risk Assessment/ Risk Management
- Site Monitoring/ Site Management/ Study Management/ Trial Management
- Good Clinical Practice/ GCP
- Clinical Data