Finally: Clinical Trial Speed and Quality


Clinical operations quality control is a major issue in today’s Life Sciences market. The current method of getting drugs and medical devices through the clinical trial process is broken because of a lack of process transparency and data holes. According to CenterWatch, 86 percent of clinical trials experience delays, due to a data quality gap. Additionally, under 10 percent of clinical trials are completed on time. The root cause: poor data quality that slows down results and go-to-market. Old processes will no longer work and Life Sciences companies need to embrace the power of new technologies to modernize clinical trials.
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Trends in Enforcement Actions – What 2014 Can Tell Us about the Road Ahead


Changes in international legislation and trends in enforcement have continued to be a moving target for 2014 and 2015. In the area of FCPA enforcement, several trends provide guidance on what companies need to be conscientious about in the coming year. In the area of international regulations, there continues to be an upswing in the number of countries that have added new regulations or tightened requirements around existing legislation to send a message regarding their efforts to reduce corruption.
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Health Check: How CAPA Programs Reveal the Real Ailments Affecting Quality


Quality control is a vital component of any pharmaceutical manufacturing facilities operations. It is the system of checks and balances that ensures a safe, high-quality product.
 
The Quality Management System (QMS) provides the written policies and procedures ensuring products are safely and consistently manufactured to meet approved quality standards.  A robust QMS of an aseptic processing facility is predicated on contamination risk management. Well documented risk assessments should be site specific and take into account not just the basic elements of good aseptic practices, but also a full evaluation of all potential contamination ingress (component flow, personnel flow, process flow).  The assessment should then drive all future decisions that build a quality by design system. [Read more…]

Using Data Analytics and Enhanced Monitoring Techniques to Avoid Government Enforcement and Individual Liability


Assessing your 2015 Compliance Goals
 
It is hard to believe that we are half way through the year.  Now entering prime vacation season, the office tends to be a little quieter and the work flow slower.  This brief reprieve from the office hustle and bustle provides compliance professionals a great opportunity to look back at what has been accomplished thus far this year and prepare for what is to come as we quickly move into the second half of the year.  Whether you started the year by conducting a formal risk assessment and prepared a formal remediation and compliance plan, or simply jotted some compliance goals on the office whiteboard, now is the perfect time to check the boxes on the tasks that were completed and see what is left to do.  It is also important to ensure the plan you put in place at the beginning of the year still “makes sense” both based on your internal business environment as well as enforcement trends and expectations for the year made known by government agencies such as the DOJ and OIG.  Taking advantage of the slower summer to do these things now will prove invaluable so that you can hit the ground running in the fall with a focused and achievable compliance game plan that will allow you to check the boxes all the way down your list.
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Six Tips for Leveraging Values, Ethics and Compliance in Successful Drug Development


CMOs play several valuable roles for emerging pharma companies: manufacturer, sounding board, safety net, among others. Battle-tested, with skills honed through years of working with large pharmaceutical companies and the FDA, CMOs uniquely know the lay of the land and can help guide emerging pharma companies along the right path. Values, ethics and compliance are integral to the CMO’s ability to maintain high professional standards and pass along good practices to their customer base. For emerging pharma companies, choosing a CMO with these qualities can make the difference between success and failure.
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Pharma Under Pressure – Four Keys to Ensuring Quality


Today’s pharmaceutical companies are feeling pressures like no other time in their history. They are expected to deliver safe and effective products with payers expecting an available supply of low cost products. There is a focus on growth opportunities in emerging markets, researching innovation through collaboration with industry and academic partners, reinventing traditional sales, marketing and R&D operating models with a focus on operational efficiency. These pressures have forced companies to look for cost savings by expanding the use of low cost suppliers and a global manufacturing supply chain of both company owned and contract manufacturing sites. At the same time they are looking to centralize and consolidate systems and processes across this complex supply chain. In response, regulators in recent years have also globalized and put agreements in place to share inspection and quality information. Generic producers are more aggressively challenging branded pharma patents, and the courts in some countries are invalidating existing patents for the general good of their population, as well as supporting local drug manufacturers. The pharmaceutical industry is now made up of a complex international supply chain that has added risk to the quality of products companies now deliver.
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