GCP Inspection Readiness
GCP Inspection Readliness

Create an interactive hands-on learning environment to discuss different approaches and strategies for achieving and maintaining and confident state of GCP inspection readiness. Leverage training and available tools ensure all stakeholders understand the expectations of them leading up to and during an inspection and the proactive preparation throughout the study that is required.

Join your peers in a candid sharing of experiences as we learn how to build a solid inspection readiness plan and execute continual proactive measures to achieve a confident state of GCP inspection readiness.

Kristen Hunter
VP, Content
MOMENTUM EVENTS

Speaking Faculty in Progress

Interested in becoming a speaker? Please contact Kristen Hunter at kristen@momemtumevents.com

Sponsors

Halloran
The Avoca Group

CONSORTIUM PARTNER

WCG Avoca Quality Consortium

SPONSORSHIP OPPORTUNITIES

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.

For more details on sponsorship and exhibition opportunities, please contact Michael Williams at michael@momentumevents.com 

Top Reasons to Attend

Discuss quality culture as the heart of any successful inspection readiness plan

Assess current inspection risks to provide the building blocks for your GCP inspection readiness plan
Utilize mock inspections as a quality tool to focus risk mitigation efforts

Understand the current regulatory environment and the impact on GCP inspections 

Harness the power of the Trial Master File (TMF) to drive inspection readiness processes
Ensure all stakeholders understand their role leading up to and during an inspection
Leverage GCP audits to assess the inspection readiness of your clinical vendors and sites
Outline sequence of events for managing an inspection to understand the different roles
Recognize training as a core component to an effective inspection readiness approach

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