2nd Annual Developing CAPAs in the GCP Environment

ExL Pharma is pleased to offer the 2nd Developing CAPAs in the GCP Environment, taking place January 19-20 again at the Westin in Arlington, VA, which remains the only forum offered on this important topic.  At this 2nd annual event, the content moves beyond theory and hypotheticals to practical case study information as companies begin to develop and implement clinical CAPA systems.  Dr. Leslie Ball, Acting Director of the Office of Scientific Investigations of FDA's CDER, will be returning to once again provide a regulatory update and share FDA's expectations for clinical CAPAs and responses to FDA warning letters.  In addition the event features numerous case studies from sponsor companies demonstrating their company's experiences with creating, integrating and applying company-wide clinical CAPA processes and systems.  The event also offers a half-day workshop, roundtable exercises and numerous panel discussions preserving the interactivity that was so valued from the first event and providing ample time for sharing experiences and brainstorming as this emerging topic takes shape and develops in the industry.  

FEATURED SESSIONS:

REGULATORY UPDATE
FDA’s Expectations for Clinical CAPAs and Reponses to FDA Warnings
Leslie K. Ball, MD, CAPT, USPHS, Acting Director, Office of Scientific Investigations, Office of Compliance, CDER, FDA

J&J CASE STUDY – IMPLEMENTING CAPA SYSTEM
Developing an Enterprise-Wide CAPA System to Support Clinical Quality
Jane Wood, Vice President, Quality Assurance, JOHNSON & JOHNSON

IMPLEMENTING FOR SUSTAINED EFFECTIVENESS
Identifying Critical Resources, Executing the CAPA and Tracking Progress to Ensure an Effective Outcome
Elizabeth Luczak, Vice President, Medical Regulatory Compliance, PFIZER, INC.

ENDO CASE STUDY - PROACTIVE COMPLIANCE MODELS
Lowering Overall Costs by Employing Proactive Approaches for Determining Potential Problem Areas that Could Require CAPAs
Sharon S. Reinhard, MS, Associate Director, Clinical Quality Control, ENDO PHARMACEUTICALS

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 is also benefits:

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