OVERVIEW In order to solve problems every organization must know how to conduct an effective investigation, perform root cause analysis, and implement workable corrective action in a timely manner. An effective CAPA process requires training internal investigators, who can also coach others in the organization, to employ critical thinking. The process must provide a common model and language within the organization, which allows investigators to master the process quickly and easily. WHY SHOULD YOU ATTEND This webinar will include discussions on proper CAPA system maintenance, root cause analysis, documentation of the Corrective and Preventative Actions and developing CAPA system. It will give tips on how to develop CAPAs pertaining to longer term projects and ensure they stay on track. AREAS COVERED • Definition of a CAPA o When a CAPA is needed o CAPA basics o Development of the essential pieces of a robust CAPA plan o CAPA best practices • Root Cause Analysis methods o Discussion of different Root Cause Analysis methods and benefits of each • Establishment of the CAPA plan o Project Summary development o Responsibilities of individuals involved o Establishing completion dates o Creating meaningful effectiveness checks • Management of the CAPA system o Maintaining proper documentation of the CAPA plans o Ensuring CAPA plans are progressing o Proper close out of CAPA plans LEARNING OBJECTIVES • Discuss what to do when problems occur • Outline the requirements of the CAPA process and procedure including building a CAPA file • Choose the most appropriate Root Cause Analysis methods for the situation • Establishing a CAPA plan: project summary, individual responsibilities and expected completion dates • Management and oversight of the CAPA management system and its documentation WHO WILL BENEFIT • Quality Control Personnel & Management • Manufacturing Personnel & Management • Senior Management • Regulatory Affairs Personnel & Management • Quality Assurance Personnel & Management • Supplier Quality Personnel & Management SPEAKER Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet regulatory compliance. Use Promo Code SPRS20 and get flat 20% discount on all purchases. To Register (or) for more details please click on this below link: http://bit.ly/2uolIqG Email: [email protected] Toll Free: +1-888-300-8494 Tel: +1-720-996-1616 Fax: +1-888-909-1882