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Developing CAPAs In GCP Environment, 24-25 January 2013, Arlington, VA

In both January of 2011 & 2012 at ’s first and second Clinical CAPAs Events, Dr. , MD, CAPT, USPHS, Acting Director, Division of Scientific Investigations, , , FDA participated as the keynote speaker and presented FDA/’s expectations for the industry’s approach to clinical CAPAs. Her presence and the content she delivered clearly outlined the shift in the FDA’s approach for assessing data integrity, which is driving the necessity for the industry to understand, develop and executive corrective and preventive actions in the GCP environment.

Join us January 24-25, 2013 in , VA at our 3rd Annual Developing CAPAs in the GCP Environment Conference, the only event for clinical quality, compliance and operations professionals to gather, discuss and share best practices on this emerging topic. Expected to draw over 125 clinical executives from leading pharma, biotech and medical device companies, the event promises to be a dynamic and interactive educational experience providing applicable and practical information for everyone in attendance to take away and implement.

Featured Sessions:

Case Study – CAPA System Implementation in a Large R&D Organization
One Approach to Developing and Executing an Effective CAPA System to Support Clinical Quality
Pearl Boakye, Head, CAPA Management, BAYER

Effectiveness Measures
How and When to Assess Whether the Clinical CAPA was Effective to Determine Next Steps
Elizabeth Luczak, Vice President, Medical Regulatory Compliance, PFIZER, INC.

Understanding the Purpose of a Root Cause Analysis and How to Effectively Conduct the Investigation
Venessa Galate, Associate Director, Therapeutic Area Clinical QA – Cardiovascular, JANSSEN PHARMACEUTICALS

Assigning Criticality & Mitigating Risk
Establishing Criticality Levels Based on Risk to Effectively Prioritize the Clinical Root Cause Analysis and CAPA
Kevin Wilson, Root Cause Analysis and CAPA Consultant, ELI LILLY

Defining Clinical CAPA
Identifying and Recognizing the Many Different Definitions of Clinical CAPA and the Varying Criteria That are Used
Krista Kerr, Associate Director, Global Systems Quality Assurance, JANSSEN PHARMACEUTICALS

Plus interactive Panel Discussions where varying company types and sizes weigh in on the following topics:

  • Conducting an Effective RCA: Experts Share their Company’s Processes, Best Practices and Lessons Learned when Conducting Root Cause Analyses
  • Implementing CAPA Systems: Varying Companies Share Challenges and Best Practices when Developing and Implementing a Clinical CAPA System
  • Escalation and Close Out: Comparing Varying Company’s Criteria and Strategies for Assessing Clinical CAPA Effectiveness and Determining when to Escalate or Close Out
  • CAPA Definition and Internal Responsibilities: How Different Companies Define Clinical CAPAs and the Responsibilities of Compliance and QA

Click here for the complete agenda.

Half-Day Interactive Workshops:
Don’t Miss our Pre-Conference Workshops. Choose your preferred topic from the following half-day workshops for intensive learning mixed with interactive activities.

Workshop A – CAPA: The Fundamentals
A Basic Overview of the Critical Elements of CAPA and the Processes at Each Stage

Workshop B – CAPA In GCP
Defining and Applying CAPA in the GCP Environment and Identifying Potential Challenges Unique to the Clinical Space

Who should attend?:
C-Level, Vice President, Director, Manager and Team Leader level professionals form the following departments at Pharma/Biotech companies, Medical Device Companies, CROs and other Clinical Trial Service Providers:

  • Clinical Quality Assurance
  • Clinical Quality Control
  • Quality Systems
  • Quality Training
  • GCP Compliance
  • Regulatory Compliance
  • Clinical Development
  • Clinical Operations
  • Clinical Auditing
  • Clinical Monitoring

The conference also benefits:

  • Data Management and Computer Software Vendors
  • Quality Consultants
  • Investigative Sites

Sponsors and Exhibitors:

For more information on sponsorship and exhibiting opportunities, please contact Mark Coulter at 917-258-5140 or [email protected]

3rd Developing CAPAs in the GCP Environment
Risk-Based, Practical Approaches for Developing and Executing
Effective Clinical Corrective and Preventive Actions
January 24-25, 2013

Westin Arlington Gateway
801 North Glebe Road
Arlington, VA 22203

Five ways to register:
Mail: ExL Events, Inc.
555 8th Ave, Ste 310
New York, NY 10018
Phone: 866-207-6528
Fax: 888-221-6750
Online: http://www.exlpharma.com/clinicalCAPA
Email: [email protected]

For more information contact:
Kristen Hunter
Event Director
ExL Pharma
[email protected]


ExL Pharma, a division of ExL Events, Inc., is the industry leader in developing innovative, educational conferences that serve the pharmaceutical and allied healthcare communities in the United States, Europe, Latin America and various markets. Behind our diverse pharmaceutical event portfolio, ExL’s experienced team conducts extensive market research and targeted outreach. The results translate into innovative, high-quality events designed to exceed the dynamic informational and networking needs of specific audiences and working groups.