Fremont, California (PressExposure) March 22, 2013 -- Description:
This webinar imparts to participants ways by which to overcome CAPA shortfalls.
CAPA is considered the central element of Quality Management Systems. Despite this fact; and given that FDA and regulatory agencies closely inspect how pharmaceutical companies conduct their investigations, it is due toCAPA deficiencies that a significant number of FDA 483 observations and Warning Letters are cited. So, it is crucial for medical device companies to get their CAPA system right to get regulatory approval. This session will also cover regulatory requirement for a CAPA system.
Having an effective CAPA documentation and tracking system is crucial to pharmaceutical operations because this system allows personnel to identify the root cause, corrective action taken, and verification stages. This session will discuss theimportant components with which to create an effective CAPA system and determine different levels of actions to be taken, and explains what training is needed to prevent reoccurrence.
This webinar will cover the following areas:
o Why an effective CAPA system is important
o Roles and responsibilities of manufacturers
o Identifying sources of infractions
o Determining root causes
o CAPA Tracking System and documentation
When:April 9, 2013, 2013,10:00 AM PDT | 01:00 PM EDT
Kim Huynh-Ba is the Executive Director of Pharmalytik, where she provides consulting and training services to pharmaceutical companies, including companies operating under FDA's Consent Decree on harmonization and optimization of analytical best practices. She has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences.
Kim is also a short course instructor on cGMP compliance and quality topics for several global organizations and many other international training groups. She is an Adjunct Professor at Temple University-School of Pharmacy, Widener University and Illinois Institute of Technology (IIT) teaching pharmaceutical analysis and analytical chemistry graduate courses. Kim is a member of the Executive Committee of Governing Board of Eastern Analytical Symposium (EAS) and will be their 2013 President. She is the Chair of USP Good Documentation Practices Expert Panel (2010-15) and a member of USP Impurities of Drug Products Expert Panel (2012-15). Kim is a recipient of the 2008 Service Award of Analysis and Pharmaceutical Quality Section and 2008 Recognition Award of Regulatory Section of AAPS. She also received the 2001 DuPont Pharmaceutical Company Asian American Leadership Award.
The webinar will benefit
o Laboratory Analysts
o Quality Assurance scientists
o QA/QC analysts
o QA/QC managers
o Pharmaceutical development and manufacturing personnel
o Manufacturers of raw materials and excipients
o Contract laboratory Organization personnel.
Duration: 60 minutes
To enroll for this webinar, contact