Implementing an Effective CAPA System: cGMP, Root Cause Analysis (RCA), Investigation and Risk Asses
- Start Date:
- Monday, 11 September, 2017
- End Date:
- Tuesday, 12 September, 2017 4:30pm
- Business Practice
One of the fundamental concepts of cGMP is that companies that manufacture or test medicines should have systems in place that ensure the safety, purity and efficacy of the marketed drugs. One of the pillars of this philosophy is that companies must be self-healing to maintain a State of Control; in other words, when a problem arises, that problem can be detected and subsequently corrected. The current expectation for US and EU regulators is that the Deviation/CAPA systems that are in place should be robust enough to Detect an event; put temporary measures in place to contain the problem; have a team of experts trained to investigate and determine root cause; then put a solution in place that stands the test of time.Whether the event occurs with a patient in the market or on the shop floor or in the lab, the progression is always the same:Event Detection → Investigation → Root Cause Analysis → Testing of Root Cause → Development of Solution → Test & Implementation of a Solution → Verification that the Solution is Robust (Effective).With the advent of ICH-Q9, all of the above steps are required to be performed within the context of Risk Analysis and Impact Assessment.
Who will Benefit:This course is designed for people throughout the GMP Operations. As deviations can occur anywhere within the GMP environment it is imperative that all personnel have some understanding of Investigation and the functions of CAPA. In addition, there also need to be some few select SMEs within the organization to guide with process / compliance knowledge as required. While it is the Quality Unit that owns the systems, it is operation personnel who are most familiar with the occurrence of events and have specific process knowledge to determine the potential source of the Root Cause.
Note: Use coupon code REFERRAL10 and get 10% off on registration.For Registration:http://www.complianceonline.com/capa-cgmp-root-cause-analysis-rca-investigation-and-risk-assessment-seminar-training-80497SEM-prdsm?channel=meetings4docs
Conference organized by ComplianceOnline
Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality, under a code of ethics, and with process discipline to ensure greater shareholder returns.Keeping things simple and straight forward, so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.
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