Virtual Program: Developing and Sustaining Quality Management Systems in Compliance with Pharma Industry Standards
March 12, 2019 - Online MD USRegulatory Affairs Professionals Society (RAPS)
jwon@raps.org
Phone:3017702920
Over the past few years there has been a growing expectation and increased standardization for Quality Management Systems (QMS) as it relates to clinical research in the pharma industry. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E6 revision was just one example of a response to the need and demand for a more robust and documented system to ensure that procedures are established, and processes are in place to monitor compliance and analyze issues when they occur. This program will address the growing requirements and expectations as it relates to root cause analysis, corrective and preventative action plans and implementation, aspects of a robust quality assurance program and how quality control can minimize errors and other quality issues. This program will support both the new and seasoned QMS manager or stakeholder to better understand the requirements, current industry trends for application and give them sample tools that can be used for quality management. Upon conclusion of the program, you will be able to: 1) Identify and interpret regulatory requirements and industry standards as it relates to the development and maintenance of a QMS. 2) Provide input to a pharma organization regarding the rationale for a QMS including Quality Assurance and Quality Control programs. 3) Understand the basic elements of a root cause analysis (RCA) and corrective and preventative action (CAPA) plan. 4) Choose at least one tool for performing and documenting an RCA and/ or CAPA.