Regulatory Compliance and Quality Systems: How to Make Sure You’re Up-to-Speed
Getting the latest information on emerging initiatives could be instrumental in your company’s success. If you would like to gain in-depth knowledge about the very latest in regulations and quality manufacturing, attend ISPE 2015 Annual Meeting. At this year’s meeting, we’ll dive into a variety of important topics during the Regulatory Compliance and Quality Systems Track, comprised of more than 16 engaging education sessions.
Among many key presentations during this track, ISPE will introduce our Drug Shortage Assessment and Prevention Tool.
This tool identifies points to consider when assessing the gap between current operations and the desired state of a robust quality system, supportive quality culture, appropriate business continuity plans and well-qualified employees. It can be used by anyone involved in the operation of a pharmaceutical supply chain for investigational or commercial product.
In order to maintain first-rate regulatory and quality processes, it’s important for us to consistently keep up-to-date on emerging regulations. For instance, the FDA’s recent draft Request for Quality Metrics Guidance for Industry could have a huge impact on the way our industry operates.
Participants of the Regulatory Compliance and Quality Systems will gain expert knowledge from FDA regulators about Quality Metrics in a special 2-part session. In these sessions, you’ll have the chance to voice your questions and concerns about the FDA’s proposed Quality Metrics Program . You will also hear case studies on the challenges and successes of standardized metrics reporting from participants of the ISPE Quality Metrics Pilot Program.
Gain the information you need to help your company progress. Register for Annual Meeting today.