The FDA has announced plans to transition to standard ISO 13485:2016 for medical devices in 2019. In addition, the Medical Device Single Audit Program, MDSAP, has gained traction with full implementation set for 2019.
Download this paper to learn more about these two changes from the U.S. Food and Drug Administration’s proposal to harmonize and modernize its Quality System Regulation (QSR).
Cost reduction is a key criteria that executives often use when choosing initiatives to focus on. They are the ones that have the greatest potential to impact an organization's bottom line. Across life science organizations, a critical area for cost containment is training management.
This paper summarizes the results of a quantitative benchmarking survey to over 200 Life Science organizations. The study identifies the key compliance and performance improvement training topics they had addressed in 2011 along with key issues for 2012.
SOPs are critical to efficient manufacturing operations, quality control, and regulatory compliance. This paper reviews best practices for the Life Science industry for training on SOPs, and how learning management technology has the potential to improve learner retention through automated assessments.
Third party intermediaries have played starring roles in some of the most highly publicized global corruption trials. By any measure, third party intermediaries routinely rank high on the list of compliance worries for brand companies.
Good Manufacturing Practices (GMP) violations have become the new healthcare fraud as the Department of Justice (DOJ) tests out new legal theories under the False Claims Act (FCA). The Food and Drug Administration (FDA) has dusted off its regulatory authority to prosecute GMP violations.
The global financial crisis of 2008 still reverberates today. Sluggish economic growth, stricter regulatory requirements and rapidly changing consumer behavior are placing unprecedented demands on the banking industry. In recent years, banks – particularly those with substantial retail operations – have relied on the lethargy of their customers to maintain their business. Customer loyalty has been based more on proximity of local branches and convenience of ATM networks than the quality of customer care or products and services priced and tailored to a bank’s best customers. In response to the financial crisis, banks have focused on wringing complexity and costs from their systems – exacerbated by mergers and acquisitions – while dealing with new and tighter regulations. Yet, their traditional “one-size-fits-all” mass-marketing approach to customers has remained constant.
Credit Union Times is the nation's leading independent source for breaking news and analysis for credit union leaders. For more than 20 years, Credit Union Times has set the standard for editorial excellence and ethical, straight-forward reporting.