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iso 13485

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Published By: ETQ     Published Date: Jul 10, 2019
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).
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ETQ
Published By: UL EduNeering     Published Date: Jul 05, 2012
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.
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fda, gmp, gcp, gxp, cms, osha, qsr, 21 cfr part 11, regulatory compliance, pharmaceuticals, medical device, good manufacturing practices, quality system regulation, online compliance training, part 11 compliance, fda part 11 compliance, iso 13485, quality management system, life science, health care
    
UL EduNeering
Published By: UL EduNeering     Published Date: Jul 05, 2012
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.
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fda, gmp, gcp, gxp, cms, osha, qsr, 21 cfr part 11, regulatory compliance, pharmaceuticals, medical device, good manufacturing practices, quality system regulation, online compliance training, part 11 compliance, fda part 11 compliance, iso 13485, quality management system, life science, health care
    
UL EduNeering
Published By: UL EduNeering     Published Date: Jul 05, 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.
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fda, gmp, gcp, gxp, cms, osha, qsr, 21 cfr part 11, regulatory compliance, pharmaceuticals, medical device, good manufacturing practices, quality system regulation, online compliance training, part 11 compliance, fda part 11 compliance, iso 13485, quality management system, life science, health care
    
UL EduNeering
Published By: UL EduNeering     Published Date: Jul 05, 2012
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.
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fda, gmp, gcp, gxp, cms, osha, qsr, 21 cfr part 11, regulatory compliance, pharmaceuticals, medical device, good manufacturing practices, quality system regulation, online compliance training, part 11 compliance, fda part 11 compliance, iso 13485, quality management system, life science, health care
    
UL EduNeering
Published By: UL EduNeering     Published Date: Jul 05, 2012
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.
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fda, gmp, gcp, gxp, cms, osha, qsr, 21 cfr part 11, regulatory compliance, pharmaceuticals, medical device, good manufacturing practices, quality system regulation, online compliance training, part 11 compliance, fda part 11 compliance, iso 13485, quality management system, life science, health care
    
UL EduNeering
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