

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.

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!
SPONSORSHIP OPPORTUNITIES are available
Sponsorship is a great way to enhance your brand’s visibility and help you connect with 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