2015 PDA/FDA Joint Regulatory Conference
It is important that organizations continue to improve and adequately resource change management systems. Key considerations for organizations include management accountability for supporting needed changes, and linking change management to the quality risk management system to ensure that the change is carefully managed and change effectiveness is verified. he critical underpinning of all of these quality system efforts is a strong quality culture. With this in mind, the FDA and PDA are again collaborating to plan the 2014 PDA/FDA Joint Regulatory Conference. The objectives for this collaboration are to promote the adoption of more robust design practices, quality systems, and use of modern manufacturing technology with the ultimate goal of improving medical products quality for the consumer.