part 11 compliance

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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
Published By: SyberWorks     Published Date: Oct 21, 2008
The e-Learning industry has grown tremendously since the early days of computers and the Internet. Today there are lots of products and services out in the market place from which to choose. This white paper will provide some basic information to help you as you begin your research into e-Learning and learning management systems. The document is not meant to be the complete source of information on e-Learning nor will these guidelines be suitable for every single situation. This white paper has been created as a learning aid help you get started. These findings represent the research, experience, and techniques gleaned from working in e-Learning since its infancy in the late 80’s to today. At the end of the paper, Bob Goldschneider, Director of Business Development at SyberWorks, Inc., will provide a summary and closing remarks.
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syberworks, e-learning, internet, aicc, scorm, learning management systems, learning management system, e-learning, elearning, web based training, training management systems, training management system, online training software, web based training software, e-learning, sop automation, seminar logistics, classroom management, online survey tool, competency management
    
SyberWorks
Published By: SyberWorks     Published Date: Oct 21, 2008
In most cases, the biggest quandary an organization must solve is to put together a rational, i.e., a cost justified, business case why they should spend capital to invest in a learning management system. The focus of this white paper will outline the benefits of web-based training along with a practical framework for developing ROI when looking at the cost of traditional training methods verses e-Learning.
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syberworks, e-learning, roi, global workforce, just-in-time learning, learning management systems, learning management system, e-learning, elearning, web based training, training management systems, training management system, online training software, web based training software, e-learning, sop automation, seminar logistics, classroom management, online survey tool, competency management
    
SyberWorks
Published By: SyberWorks     Published Date: Oct 21, 2008
This blind case study focuses on the operations division of a Fortune 500 company had significant challenges training its franchisees. They struggled with an 8 to 12 month backlog in providing training for their new franchisees coming on board. Anecdotally, when they did get around to training new people, the requirements and curriculum were outdated and in the process of being revised. Their franchisees and employees were never current on updated company policies and procedures. These franchises were spread all over the country, so it was costly to train their franchisees using traditional onsite training methods.
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syberworks, learning management system, roi, learning management systems, learning management system, e-learning, elearning, web based training, training management systems, training management system, online training software, web based training software, e-learning, sop automation, seminar logistics, classroom management, online survey tool, competency management, schedule simulation, fda 21 cfr part 11
    
SyberWorks
Published By: SyberWorks     Published Date: Oct 21, 2008
Jean Ann Larson, Chief Learning Officer (CLO), and Tawanna Foggs, Educational Systems Coordinator, of William Beaumont Hospitals, talk about their use of the SyberWorks Learning Management System to train and certify hospital employees.
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syberworks, learning management system, learning management systems, learning management system, e-learning, elearning, web based training, training management systems, training management system, online training software, web based training software, e-learning, sop automation, seminar logistics, classroom management, online survey tool, competency management, schedule simulation, fda 21 cfr part 11, compliance management
    
SyberWorks
Published By: SyberWorks     Published Date: Oct 21, 2008
Claudia Innes, Corporate Marketing Director for Fairchild Semiconductor, Inc. discusses their use of the SyberWorks Hosted e-Learning Solution to create a marketing-information portal to provide marketing and performance support for their sales staff, sales engineers, partners, and distributors in the power-supply segment.
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syberworks, e-learning, elearning, performance support, learning management systems, learning management system, e-learning, web based training, training management systems, training management system, online training software, web based training software, e-learning, sop automation, seminar logistics, classroom management, online survey tool, competency management, schedule simulation, fda 21 cfr part 11
    
SyberWorks
Published By: SyberWorks     Published Date: Oct 21, 2008
Kevin Lange, Director of Field Training at Service Master Clean, Inc., talks about his company's training program and the organizational drivers that led them to consider an e-learning program and to choose the SyberWorks Training Center Learning Management System to manage their training.
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syberworks, e-learning, elearning, training program, drivers, learning management systems, learning management system, e-learning, web based training, training management systems, training management system, online training software, web based training software, e-learning, sop automation, seminar logistics, classroom management, online survey tool, competency management, schedule simulation
    
SyberWorks
Published By: IBM     Published Date: Sep 18, 2008
When bound to regulation and compliance, process manufacturers find opportunities to grow through enterprise resource planning (ERP). However, 50% of process manufacturers execute non-integrated ERP strategies. This Aberdeen Group research study reveals best practices to help you adapt or select an ERP vendor that improves your business performance.
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erp, enterprise resource planning, cindy jutras, process, process industry, chemical, food and beverage, food, beverage, pharmaceutical, pharma, best-in-class, material requirements planning, mrp, global competition, manufacturing process, microsoft dynamics, acsis, fullscope, traceability
    
IBM
Published By: Ecora Software     Published Date: Aug 15, 2007
21 CFR Part 11 continues to cause confusion. Recent FDA guidance documents help, but many IT departments still struggle to establish appropriate validation processes with limited time and resources. Ecora's FREE in-depth guide, "Achieving Sustainable IT Compliance to 21 CFR Part 11," gives you an overview of the regulation from an IT perspective. It also outlines how you can accurately and cost-effectively implement a systems-based best practices approach that will help you meet FDA requirements.
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21 cfr part 11, compliance, electronic records, electronic data, electronic signatures, information management, pharm, pharmaceuticals, drug, fda, electronic signature, digital signature, audit, auditing, fda, compliant, ecora
    
Ecora Software
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