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

Date: Jan-15-2013Dr. 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
Courtesy: Medical News Today Note: Any medical information available in this news section is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional.