GCP Inspection Readiness

Featured Presentations

FDA KEYNOTE: GCP INSPECTION UPDATE
Examine Recent BIMO Updates as well as GCP Inspection Trends, Metrics and Regulatory Actions

Chrissy J. Cochran, Ph.D.
Director, Office of Bioresearch Monitoring Operations, ORA
FDA

PROACTIVE QUALITY BRIEF
Maximize Transparency with Health Authorities through Submission of Proactive Quality Briefs to Streamline Approvals and Facilitate Inspections

Paula Walker
Quality Policy Chapter Lead, PDQ
ROCHE
Former Head of Compliance
MHRA

GCP Inspection Readliness

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.

Kristen Hunter
VP, Content
MOMENTUM EVENTS

SPEAKER HIGHLIGHTS

Liz Bodi
Liz Bodi

Principal Consultant, Organizational and Quality Solutions
HALLORAN CONSULTING GROUP

Chrissy J. Cochran, Ph.D.
Chrissy J. Cochran, Ph.D.
Director, Office of Bioresearch Monitoring Operations, ORA

FDA

Donna Dorozinsky
Donna Dorozinsky

President & CEO
JUST IN TIME GCP

Susan Greenbowe
Susan Greenbowe

Executive Director, Clinical QA
CHINOOK THERAPEUTICS

Susan Johansson
Susan Johansson

Senior Director, Clinical Operations
MATINAS BIOPHARMA

Dawn Lundin
Dawn Lundin

Head of Global Quality
MAPS PBC

Crissy MacDonald, Ph.D.
Crissy MacDonald, Ph.D.

Vice President, Client Delivery
WCG AVOCA

Dawn Niccum
Dawn Niccum

Executive Director, QA and Compliance
INSEPTION GROUP

Lynn O’Connell
Lynn O’Connell

Director, Clinical Quality Management, Global Clinical Operations and Planning
DAIICHI SANKYO

Loreena Sadowski
Loreena Sadowski
Senior Director RDQ-Clinical Inspection Management

BRISTOL-MYERS SQUIBB

Tim Stoddard
Tim Stoddard
Quality Consultant/Advisor; Previous Head of Quality,
FLATIRON HEALTH
Previous Clinical Quality Leader
SPARK THERAPEUTICS
Wendy Trimboli
Wendy Trimboli
Executive Director, Clinical Operations Process, Systems and Inspection Readiness
ACADIA PHARMACEUTICALS INC.
Paula Walker
Paula Walker
Quality Policy Chapter Lead, PDQ,
ROCHE
Former Head of Compliance,
MHRA
Michael Wieczerzak, MS, MBA, MPH, CCRP
Michael Wieczerzak, MS, MBA, MPH, CCRP

Associate Director, Clinical Quality Management Lead
EMD SERONO

Sponsors

Logo of DArcy Compliance Consulting, Tagline, We Build Compliance Cultures
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