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CHANGE CONTROL FOR FDA REGULATED INDUSTRIES: A RISK ASSESMENT APPROACH David N. Muchemu
Publisher: Authorhouse

Dec 13, 2013 - Agency officials late last year proposed a benefit-risk assessment that they say would provide a more consistent pathway to approval. During the past 10 years, however, there have been global regulatory changes toward risk-based and lifecycle approaches to cGMPs and regulatory issues relating to chemistry, manufacturing, and controls led particularly by FDA. At Sparta Systems, we have a number of employees who have come from the life sciences industry and are able to offer different viewpoints on certain topics based on their specific experiences. To the product requirements, and the iterative and incremental nature of Agile development, it is essential that the development organization have robust software configuration management systems and a streamlined, responsive change management process. Oct 29, 2011 - Proactive identification of potential risks resulting out of non-compliance to good manufacturing practices (GMP) is a challenge to the industry and therefore production plants require continuous assessment of the activities through stringent audits, according to SM Mudda, It recommends a quality system based and risk-based approach for regulation of pharmaceutical cGMP. For example, in a non-regulated environment, backlog grooming and story definition would likely not involve any explicit, formal risk assessment and mitigation. Transfer – move to group/organization/supplier to address. Mar 3, 2014 - Focusing on the constitutive and performative power of expertise, I will demonstrate that global environmental assessments such as the IPCC are important sites of co-production, where knowledge about the natural world is made within, and .. Jan 13, 2014 - Let's focus on the medical device industry. Mar 19, 2014 - No doubt FDA comes across this regularly. I interviewed three such individuals They are also looking to see that system access is controlled and monitored. This is where the US FDA adopted ICH Q9 Quality Risk Management in June 2006. Jun 20, 2013 - By adopting a risk-based approach, organizations can more efficiently validate systems while still adhering to regulation requirements. Jan 25, 2012 - This approach led to redundancy in documentation and testing, and caused delays in project schedules from changes made in the process to meet quality expectations. Jul 2, 2013 - It is clear that the pharmaceutical industry lags behind many other areas of manufacturing with respect to its approaches to quality and risk management. In 2002, the FDA announced its initiative for the 21st century, which introduced the concept of Risk Management and Quality by Design. Avoidance – redefine plans, requirements, technical approach. The International Application of the risk assessment should also be consistent over the project to achieve the benefits of the ASTM E2500 approach. Jul 1, 2011 - In two of the most regulated markets — aerospace and medical — the operating authorities (FAA and FDA) are levying requirements for the performance and documentation of risk management, including allocating risk down to the Figure 1 Risk Assessment Process (Source: FAA Air Traffic Organization – Capt Bill Yantiss TASS 11/9/2009). The assessment would take “We are moving away from our 'one-size-fits-all' approach to clinical trial outcomes for these devices,” FDA officials wrote.