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DTSTART;VALUE=DATE:20180222
DTEND;VALUE=DATE:20180224
DTSTAMP:20171213T222737Z
CREATED:20171213T222737Z
LAST-MODIFIED:20171213T222737Z
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SUMMARY:What are Data Integrity Issues? Types of Data Integrity Issues 2018
DESCRIPTION:Venue: Four Points by Sheraton Los Angeles International Airport\n9750 Airport Boulevard\, Los Angeles\, CA\, 90045 \nCourse “A Risk Based Approach To Data Integrity” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion. \nOverview:  \nThe impact of Data Integrity issues on a regulated company can be significant: it can result in recalls of products\, warning or untitled letters\, import alerts\, injunctions\, seizures\, legal action\, etc. These regulatory actions can have significant financial impact to the company. However\, and most importantly\, data integrity issues can lead to potential patient harm!!\nDefined by the Medicines and Healthcare Products Regulatory Agency (MHRA) as “the extent which all data are complete\, consistent and accurate throughout the data lifecycle”\, data integrity is increasingly the focus of regulatory agencies round the world. Companies must now ensure that they are appropriately addressing data integrity and data governance. This includes organizational\, procedural and technical controls that must be considered as part of an overarching data governance system. In addition\, the effort and resources committed to data integrity must be commensurate with the role it plays in assuring product quality.\nTo ensure Data Integrity\, a GxP regulated company needs to abide by principles\, current regulations and industry best practices on the expectations for the management GxP regulated records and data. These principles\, regulations and best practices\, ensure that data is complete\, consistent\, accurate\, secure and available throughout the record life cycle. This approach is intended to encourage innovation and technological advances while avoiding unacceptable risk to product quality\, patient safety and public health.\nKey implementation considerations for a corporate data integrity program\, include development of a high-level strategy\, identifying and gaining executive sponsorship\, focusing on management accountability\, implementing tools for knowledge sharing and developing and providing the appropriate levels of training. An effective data integrity program includes addressing of behavioral factors and drives a strategy that focuses on prevention\, detection\, response and continuous improvement. \nThe Seminar: \nThis Seminar addresses the integrity of GxP records and data used within the regulated industries including pharmaceutical\, biological\, medical devices\, cosmetics\, food and any other industry where data integrity is important. It provides a method for managing risk to record and data integrity. Learning Objectives for the seminar include:\n• Data Integrity Requirements\n• Critical Areas of Regulatory Focus and Concern\n• Key Concepts\n• A Framework for Data Governance and Human Factors\n• A Complete Data Life Cycle Approach as Part of a Quality Management System\, from Creation to Destruction\n• How to Apply Risk Management to Data Integrity \nWhy you should attend: \n• VP of IT\n• Director of IT\n• Quality Managers\n• Project Managers (for CSV / IT)\n• Validation Specialists\n• Database Administrators\n• System Administrators\n• Directors / Senior Directors of Discovery\n• Directors / Senior Directors of Development\n• Directors / Senior Directors of Commercialization\n• Document Managers\n• Training Managers\n• Regulators\n• Vendors\n• Suppliers\n• Outsource Service Providers \nIndustries: \n• Pharmaceuticals\n• Biotech\n• Medical Device\n• Radiological Health\n• Blood Products\n• Companion Animals\n• Food\n• Cosmetics\n• Tobacco\n• Academia \nAgenda: \nDay 1 Schedule \nLecture 1:\nIntroduction and Background\n• Introductions / Participants’ Understanding / Participants’ Objectives for the Course (Please come prepared to discuss)\n• Regulatory Focus\n• Data Integrity Requirements\nLecture 2:\nData Governance Framework\n• Elements of the Data Governance Framework\n• Human Factors in Data Integrity\n• Data Integrity Maturity Model\nLecture 3:\nQuality Risk Management\n• Process Risk Management\n• Quality Risk Managemet\n• Product and Process Context\nLecture 4:\nData Life Cycle\n• Data Creation\n• Data Processing\n• Data Review\, Reporting and Use\n• Data Retention & Retrieval\n• Data Destruction\n• Integrating Data Integrity into Existing Records Management Process \nDay 2 Schedule \nLecture 5:\nData Integrity Management\n• Corporate Data Integrity Program\n• Data Integrity Maturity Model\n• Human Factors\n• Inspection Readiness\nLecture 6:\nAuditing & Audit Trails\n• Data Audit Trail\n• Audit Trail Review\n• Data Auditing\n• Periodic Review\nLecture 7:\nData Integrity for Electronic Records / Electronic Signatures (ERES)\n• User Requirements\n• Process Mapping & Interfaces\n• Controls for Electronic Records / Electronic Signatures\n• Data Integrity for Spreadsheets & End-User Applications\n• Data Integrity for IT Infrastructure\nLecture 8:\nData Conversions\n• Retention\, Archiving & Migration\n• Paper Records & Hybrid Situations\n• Converting Electronic to Alternative Format or Alternative Format Hybrids\nQuiz: Jeopardy!!!!\n• Data Integrity \nSpeaker\nAngela Bazigos\nCEO\, Touchstone Technologies Silicon Valley \nSeasoned Executive with 40 years of experience in the Life Sciences & Healthcare Industries. Positions include Chief Compliance Officer http://morflearning.com/angelabazigos/. Experience combines Quality Assurance\, Regulatory Compliance\, Business Administration\, Information Technology\, Project Management\, Clinical Lab Science\, Turnarounds and Business Development. Past employers / clients include Roche\, Novartis\, Genentech & PriceWaterhouseCoopers. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashx Patent on speeding up software compliance https://www.google.com/patents/US8266578. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom http://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/ National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for LifeSciences: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview. \nLocation: Los Angeles\, CA Date: February 22nd & 23rd\, 2018 and Time: 9:00 AM to 6:00 PM\nVenue: Four Points by Sheraton Los Angeles International Airport 9750 Airport Boulevard\, Los Angeles\, CA\, 90045\, United States \nPrice: \nRegister now and save $200. (Early Bird)\nPrice: $1\,295.00 (Seminar Fee for One Delegate)\nUntil January 10\, Early Bird Price: $1\,295.00 From January 11 to February 20\, Regular Price: $1\,495.00\nRegister for 5 attendees Price: $3\,885.00 $6\,475.00 You Save: $2\,590.00 (40%)*\nRegister for 10 attendees Price: $7\,122.00 $12\,950.00 You Save: $5\,828.00 (45%)* \nSponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar\nAt this seminar\, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices\, regulatory updates\, changes in technologies\, and much more relating to FDA Regulated Industry.\nAs a sponsor of these seminars\, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars\, you also get talked about frequently in our correspondences with our experts and these participants.\nFor More Information- https://www.globalcompliancepanel.com/control/sponsorship
URL:https://ndnr.com/event/what-are-data-integrity-issues-types-of-data-integrity-issues-2018/
CATEGORIES:Course
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20180222
DTEND;VALUE=DATE:20180224
DTSTAMP:20171213T223029Z
CREATED:20171213T223029Z
LAST-MODIFIED:20171213T223029Z
UID:27889-1519257600-1519430399@ndnr.com
SUMMARY:Quality Management System Courses | Quality Professionals 2018
DESCRIPTION:Location: Los Angeles\, CA\, 94539 \nCourse “Evolution of the Quality Management System – How to go from Surviving to Thriving” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion. \nOverview:  \nUsing lecture\, discussion\, and exercises\, this 2 day seminar will focus on taking your QMS from surviving to thriving. We’ll move from understanding the regulatory requirements\, how to create your QMS structure\, process thinking\, and developing your improvement strategy. We’ll discuss tools and techniques for improvement and how to measure your progress. \nWhy you should attend: \nMany companies struggle to establish and maintain a Quality Management System (QMS) that is both efficient and effective. An ineffective QMS leads to disastrous consequences such as medical device reports\, recalls\, 483s\, and warning letters. An ineffective QMS can result in serious consequences for your customers leading to dissatisfaction\, serious injury\, or even death. It is imperative that medical device companies can effectively establish a QMS.\nAnd an inefficient QMS results in wasted time\, money\, and missed opportunities. In this 2-day seminar\, we will use lecture\, exercises\, and discuss to learn the fundamentals of a Quality Management System and how you can take your program from surviving to thriving. A thriving QMS can help you achieve your compliance objectives and improve product quality\, leading to higher customer satisfaction and business results. \nAreas Covered in the Session: \n• Essentials of an effective QMS\n• Essentials of an efficient QMS\n• Quality is not an Organization\n• Key Capabilities\n• Maturity Modeling\n• Vision\, Strategy\, and Quality Planning\n• Improvement Tools\n• Best Practices \nWho will benefit: \n• Quality Systems Specialists\n• Quality and Compliance Specialists\n• Auditors\n• Quality and Compliance Managers and Directors\n• CAPA Specialists\n• Project Managers\n• Supplier Quality Engineers and Auditors\n• Quality Engineers\n• Management Representatives\n• General Managers \nAgenda: \nDay 1 Schedule \nLecture 1:\n• Regulatory expectations for a QMS\n• Lessons Learned from 483s and warning letters\n• Common problems and simple solutions\nLecture 2:\n• QMS Structure\n• Roles and Responsibilities\nLecture 3:\n• Management Responsibility\, Culture of Quality\, Risk Management\nLecture 4:\n• Key Capabilities for success\n• Maturity Modeling\n• QMS Evolution \nDay 2 Schedule \nLecture 1:\n• Metrics\, internal Audit\n• Cost of Quality\nLecture 2:\n• Quality Leadership\nLecture 3:\n• Vision and Strategy\n• Quality Planning\nLecture 4:\n• Improvement Tools and Techniques\n• CAPA and RCA \nSpeaker\nSusanne Manz\nQuality and Compliance Expert / Auditor for Medical Devices\, Manz Consulting\, Inc. \nSusanne Manz\, MBA\, MBB\, RAC\, CQA is an accomplished leader in the medical device industry with emphasis on quality\, compliance\, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development\, to operations\, to post-market activities. While at GE\, J&J\, and Medtronic\, Susanne worked in various world-wide roles including Executive Business Consultant\, Worldwide Director of Quality Engineering\, Worldwide Director of Design Quality\, and Director of Corporate Compliance. Susanne is a Presidential Scholar and has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and is a Certified Quality Auditor by the American Society for Quality. She has also served as a judge for the ASQ ITEA awards. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance. For more information\, visit www.ManzConsultingInc.net. \nLocation: Los Angeles\, CA Date: February 22nd & 23rd\, 2018 and Time: 9:00 AM to 6:00 PM\nVenue: WILL BE ANNOUNCED SOON \nPrice:\nRegister now and save $200. (Early Bird)\nPrice: $1\,295.00 (Seminar Fee for One Delegate)\nUntil January 10\, Early Bird Price: $1\,295.00 From January 21 to February 19\, Regular Price: $1\,495.00\nRegister for 5 attendees Price: $3\,885.00 $6\,475.00 You Save: $2\,590.00 (40%)*\nRegister for 10 attendees Price: $7\,122.00 $12\,950.00 You Save: $5\,828.00 (45%)* \nSponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar\nAt this seminar\, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices\, regulatory updates\, changes in technologies\, and much more relating to FDA Regulated Industry.\nAs a sponsor of these seminars\, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars\, you also get talked about frequently in our correspondences with our experts and these participants.\nFor More Information- https://www.globalcompliancepanel.com/control/sponsorship
URL:https://ndnr.com/event/quality-management-system-courses-quality-professionals-2018/
CATEGORIES:Course
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20180222
DTEND;VALUE=DATE:20180226
DTSTAMP:20170719T233206Z
CREATED:20170719T233206Z
LAST-MODIFIED:20170719T233206Z
UID:26375-1519257600-1519603199@ndnr.com
SUMMARY:3rd Annual Hawaii Doc Talks
DESCRIPTION:Hawaii Doc Talks 2018\, Save the Date!\n\n\n\n\n\n\n\n\n\n\nNow selling exhibit space and sponsorship opportunities!\nClick here to download the exhibitor prospectus\n\nDownload Here\n\n\n\n\nClick here to purchase a booth:\n\nPurchase Now!\n\n\n\n\n\n\n\n\nJoin us for the\n3rd Annual\nHawaii Doc Talks\nKauai Beach Resort\nFebruary 22 – 25\, 2018\n\n\n\n\n\n\nHawaii Doc Talks 2018 Call for Speakers\nThe Hawaii Doc Talks team is currently accepting applications from speakers for its 3rd Annual conference. \nPlease CLICK HERE to download the submission guidelines. \nYou can upload submissions HERE
URL:https://ndnr.com/event/3rd-annual-hawaii-doc-talks/
CATEGORIES:Conference
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Denver:20180223T100000
DTEND;TZID=America/Denver:20180223T113000
DTSTAMP:20171208T173221Z
CREATED:20171208T173221Z
LAST-MODIFIED:20171208T173221Z
UID:27776-1519380000-1519385400@ndnr.com
SUMMARY:7 Behaviors of Great Leaders
DESCRIPTION:Leadership is a noble profession. It all starts by mastering the leadership of self. Then you have the right to start to deliberately influence and lead others. The most effective way to lead is to set the example.\nYou and I have deeply developed habits of behavior. First we must discover why and how we currently handle the critical behaviors of great leadership. What is our unconscious state of mind when it comes to each habit? What do other people see when they watch us? How do we change and develop new habits? \nWe will delve into each behavior that is needed for you to be a great leader. This will include tools to help you assess yourself\, develop and design a system of follow up to insure you continue to improve. \nWhy should you Attend: You do not need to reinvent the wheel. The marks of great leaders have left a clear trail that you can choose to follow. No matter what level of leadership you are currently at\, the time to start your focused journey is now. Even if you do not lead many people\, you need to develop these habits for any success you wish to attain. \nThe remarkable thing about these habits is that they are “not rocket science” they are fundamental\, basic and common to all great leaders. The key is to realize where you are now and what exactly it is you have to change or develop to become a better leader. The journey is never over. \nThis webinar will give you concrete technics\, philosophical justification and a road map that will be simple for you to follow. \nAreas Covered in the Session: \nWhat does a great leader look like and act like?\nHow do you live with integrity as a leader?\nThe magic of self-control\, growth and caring What about attitude?\nThe primary activities of a great leader\nHow does a great leader treat others?\nThe importance of focused attention\nIt all boils down to 7 basic behaviors \nWho Will Benefit: \nCEO\, CFO\, COO\nVice Presidents and Regional Managers\nManagers and Supervisors\nNewly Promoted Managers\nHigh Potential Employees being groomed for Leadership & Promotions \nInstructor:\nDavid’s passion is helping executives create a masterpiece personally and professionally. That’s why he wrote\, “The CEO Code\,” a Best Seller on AMAZON. That success resulted in Penguin/Alpha Books asking David to write “IDIOT’S GUIDES: Management Skills” released in December 2014.
URL:https://ndnr.com/event/7-behaviors-of-great-leaders/
CATEGORIES:Webinar
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