Key Elements of ICH-Q10 Pharmaceutical Quality System
Overview:
This webinar will discuss the evolution of the standards, describe a Pharmaceutical Quality System and discuss the transition to the Pharmaceutical Quality System.
Why you should attend: The US FDA, and regulatory agencies around the world, are actively promoting the concept of a Pharmaceutical Quality System. The concept of a Quality System was imposed on the medical device industry through the implementation of a regulation - the Quality System Regulation (QSR), 21CFR820, in 1996. It is not clear when and how the FDA will begin to support its expectation for a Pharmaceutical Quality System through the inspectional process. It is clear that pharmaceutical companies should be proactively considering the implementation of a Pharmaceutical Quality System. Most people are still trying to figure out what a Pharmaceutical Quality System is. Many of the components of a Pharmaceutical Quality System are in place in most companies. The various FDA and ICH guidance documents provide significant clues as to what should be in a Pharmaceutical Quality System.
Regulatory guidance's, as well as contemporary quality standards, reference life cycle, management responsibilities, knowledge management, risk management, quality by design and many other concepts. Individuals in pharmaceutical firms, from the highest executive to the middle manager are wondering how these will fit into their organization and its Quality system, and how they will impact them, personally.
This webinar will help the participants understand what a Pharmaceutical Quality System is and how to transition from the compliance systems of today to the systems outlined in the various guidance's. It will require organizations to transition from a philosophy of test quality in and do not look beyond the words in the GMPs to a more proactive philosophy that is consistent with contemporary quality standards, such as ISO, and includes concepts such as building quality into the process and product.
By the end of this webinar, participants will better understand what is included in a Pharmaceutical Quality System, how their organization can transition to this type of a quality system and how the changes will impact them.
Areas Covered in the Session:
- The transition from a quality control focus to a quality assurance focus
Who Will Benefit: The following individuals and disciplines will benefit from this webinar:
- CEOs
- Senior Management
- VP of Quaaity
- QA Manager
- QA personnel responsible for the quality system elements