Medical Device Innovation Consortium/MDIC’s Case for Quality program today released a whitepaper recasting the Corrective and Preventive Action (CAPA) process as a continuous improvement process and to design a less burdensome process that drives higher product quality and improved patient safety. The whitepaper summarizes the initial findings and recommendations developed by a joint team from MDIC, the medical device industry, strategy consultants, and the FDA, including a proposed framework for risk-based improvement.

For more info and to download whitepaper – https://mdic.org/news/mdic-releases-case-for-quality-capa-process-improvement-whitepaper/?utm_campaign=coschedule&utm_source=twitter&utm_medium=MDIConline

This intensive 4 ½ day course provides quality system professionals with the information needed to develop and maintain a quality system program that conforms with the FDA’s Quality System Regulation (21 CFR 820) and International Organization for Standardization 13485:2016, the international standard that spells out the requirements for regulatory purposes for quality management systems.

For more info and registration:  https://my.aami.org/store/events/registration.aspx?event=QS1219

This forum brings together leading global pharmaceutical industry professionals and regulators to share their insights on technologies, approaches, and solutions that will drive innovation and quality for the medicines delivered to patients worldwide. This interactive setting with expert-led regulatory and industry presentations and forums will ensure pharmaceutical industry professionals are well-prepared to develop and apply innovative solutions in today’s global regulatory environment.

The Summit will provide attendees the unique opportunity to raise questions and engage in discussion with global regulators and industry experts.

For more info:  https://ispe.org/conferences/2019-global-pharmaceutical-regulatory-summit