 FDA Participation At 3rd Developing CAPAs In The GCP Environment Conference, 24-25 January 2013, Arlington, VAMain Category: ConferencesArticle Date: 15 Jan 2013 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:
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 Original article posted on Medical News Today. Articles not to be reproduced without permission of Medical News Today Medical News Today publishes the latest health news and health videos for consumers and health professionals. It has a searchable archive of over 100,000 health news articles. < back to medical news
|
||||
|
news headlines 
email to a friend 
printer friendly 
sign up to newsletter 
Privacy Policy | Disclaimer | Contact / Feedback
MediLexicon International Ltd
Bexhill-on-Sea, UK
MediLexicon International Ltd © 2004-2013 All rights reserved.
