FDA Participation At 3rd Developing CAPAs In The GCP Environment Conference, 24-25 January 2013, Arlington, VA

Main Category: Conferences
Article Date: 15 Jan 2013 - 7:00 PST


Dr. Jean Mulinde, Acting Senior Advisor, Division of Good Clinical Practice Compliance, Office of Scientific Investigations at CDER, FDA, has confirmed to present the following keynote address at the 3rd Developing CAPAs in the GCP Environment Conference on January 24-25, 2013 at the Westin in Arlington, VA.

KEYNOTE PRESENTATION: REGULATORY UPDATE
FDA's Expectations for Clinical CAPAs and Reponses to FDA Warnings
Jean Mulinde, MD, Acting Senior Advisor, Division of Good Clinical Practice Compliance, Office of Scientific Investigations, CDER, FDA
Overview of current inspections trends and follow-up
Commonly occurring deficiencies in CAPA
Essential event identification documentation at site and sponsor level
Preparing and providing acceptable responses to an FDA 483 or Warning Letter
Defining independent third party verification of a CAPA

Seats are limited and filling fast, so click here to reserve yours today. Use Priority Code C221PR

ADDITIONAL 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.

ROOT CAUSE ANALYSIS
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 will also benefit:
Data Management and Computer Software Vendors
Quality Consultants
Investigative Sites

VENUE:
Westin Arlington Gateway
801 North Glebe Road
Arlington, VA 22203
888-627-7076
http://www.westinarlingtongateway.com

Contact details for registration:
ExL Events, Inc.
555 8th Ave, Ste 310
New York, NY 10018
Tel: 866-207-6528
Fax: 888-221-6750
http://www.exlpharma.com/clinicalCAPA
registration@exlpharma.com

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