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What is 21 CFR Compliance | 21 CFR Part 11 Regulations 2018
Course "Validation and 21 CFR Part 11 Compliance of Computer Systems" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools The Seminar This hands-on course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation as follows: Validation Master PlanComplete Validation for a SystemExcel Spreadsheet ValidationChange ControlSOPsTest Tools ValidationProject Management for Validation Who Should Attend: VP of ITDirector of ITQuality ManagersProject Managers (for CSV / IT)Validation SpecialistsDatabase AdministratorsSystem AdministratorsDirectors / Senior Directors of DiscoveryDirectors / Senior Directors of DevelopmentDirectors / Senior Directors of CommercializationDocument ManagersTraining Managers Industries: PharmaceuticalsBiotechMedical DeviceRadiological HealthBlood ProductsCompanion AnimalsFoodCosmeticsTobaccoAcademia Agenda: Day 1 Schedule Lecture 1: Introduction/Background Introductions / Participants' UnderstandingParticipants' Objectives for the Course (Please come prepared to discuss) Lecture 2: Requirements at a High Level Types of RequirementsDifference between User Requirements & Functional Requirements Lecture 3: Detailed Requirements Study Gathering RequirementsEntity Relationship DiagramProcess DecompositionRisk Assessment for RequirementsExercise on how to create Requirements Lecture 4: Design Design SpecificationsSoftware Configuration and BuildExercise on how to create Design Specifications Day 2 Schedule Lecture 5: CSV Detailed Study (Cont'd) Traceability MatrixVerification and TestingExercise Creating Validation ScriptsExercise Creating Traceability Matrix Lecture 6: Other Documents Validation PlanTest Protocols Test Reports Validation ReportValidation Registry Lecture 7: Special Topics Project Management for CSVInfrastructure for CSVSelecting software for 21 CFR 11 ComplianceTest Tools for CSV Lecture 8: Change Control & Business Continuity Change ControlImplementing Business Continuity for CSV Speaker Angela Bazigos CEO, Touchstone Technologies Silicon Valley Seasoned 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. Location: Boston, MA Date: March 1st & 2nd, 2018 and Time: 9AM to 6PM Venue: Four Points by Sheraton Boston Logan Airport Revere, MA 407 Squire Rd, Revere, MA 02151, United States Price: Register now and save $200. (Early Bird) Price: $1,295.00 (Seminar Fee for One Delegate) Until January 20, Early Bird Price: $1,295.00 From January 21 to February 27, Regular Price: $1,495.00 Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)* Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar At 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. As 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. For More Information- https://www.globalcompliancepanel.com/control/sponsorship Contact us today! NetZealous LLC DBA GlobalCompliancePanel john.robinson@globalcompliancepanel.com support@globalcompliancepanel.com Toll free: +1-800-447-9407 Phone: +1-510-584-9661 Website: http://www.globalcompliancepanel.com Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901540SEMINAR?ticketleap-March-2018-SEO Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/ Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/ Follow us on Twitter: https://twitter.com/GCPanel Seminar Fee for One Delegate - $1295.00

When: Mar 1, 2018 9am in Revere, MA
Cost: $1295.00

Validation and 21 CFR Part 11 Compliance of Computer Systems (ntz)

Validation and 21 CFR Part 11 Compliance of Computer Systems Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools The Seminar This hands-on course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation as follows: Validation Master Plan Complete Validation for a System Excel Spreadsheet Validation Change Control SOPs Test Tools Validation Project Management for Validation Who Should Attend: VP of IT Director of IT Quality Managers Project Managers (for CSV / IT) Validation Specialists Database Administrators System Administrators Directors / Senior Directors of Discovery Directors / Senior Directors of Development Directors / Senior Directors of Commercialization Document Managers Training Managers Industries: Pharmaceuticals Biotech Medical Device Radiological Health Blood Products Companion Animals Food Cosmetics Tobacco Academia Day 1 Schedule Lecture 1: Introduction/Background Introductions / Participants' Understanding Participants' Objectives for the Course (Please come prepared to discuss) Lecture 2: Requirements at a High Level Types of Requirements Difference between User Requirements & Functional Requirements Lecture 3: Detailed Requirements Study Gathering Requirements Entity Relationship Diagram Process Decomposition Risk Assessment for Requirements Exercise on how to create Requirements Lecture 4: Design Design Specifications Software Configuration and Build Exercise on how to create Design Specifications Day 2 Schedule Lecture 5: CSV Detailed Study (Cont'd) Traceability Matrix Verification and Testing Exercise Creating Validation Scripts Exercise Creating Traceability Matrix Lecture 6: Other Documents Validation Plan Test Protocols Test Reports Validation Report Validation Registry Lecture 7: Special Topics Project Management for CSV Infrastructure for CSV Selecting software for 21 CFR 11 Compliance Test Tools for CSV Lecture 8: Change Control & Business Continuity Change Control Implementing Business Continuity for CSV Speaker Angela Bazigos CEO, Touchstone Technologies Silicon Valley Seasoned 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/ FDAhttp://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. Please contact the event manager Marilyn (marilyn.b.turner(at)nyeventslist.com ) below for:- Multiple participant discounts- Price quotations or visa invitation letters- Payment by alternate channels (PayPal, check, Western Union, wire transfers etc)- Event sposnsorshipsNO REFUNDS ALLOWED ON REGISTRATIONSService fees included in this listing.-----------------------------------------------------------------This event is brought to you by:NTZ - NewYorkEventsListhttp://www.NyEventsList.comhttp://www.BostonEventsList.comhttp://www.SFBayEventsList.com----------------------------------------------------------------- VIO171226CEV

When: Mar 1, 2018 9am in Revere, MA

ISO 13485:2016 Implementation Workshop 2018

Overview:   The medical device industry is in the midst of major change, with the publication of the FDA's UDI Regulation, the first revision to the ISO Quality Management Systems standard in over a decade, and the upcoming changes to the EU's Medical Device Regulation expected to be passed later this year. All of these events have far reaching effects on Quality Management Systems so it is critical to understand what has changed with in ISO 13485: 2016 in order to create a comprehensive quality plan for your organization to ensure continued compliance and certification. This interactive session will include lectures, roundtable discussions and activities all aimed at understanding key strategies and identifying specific actions to effectively improve Quality Management System Compliance. The program will also include detailed, step-by-step guidance on how to develop, implement and maintain strategies in order to achieve a specific goal. Participants will want to come to the sessions with a thorough knowledge of improved company strategies and a willingness to discuss aspects of it in a confidential learning environment.   Why you should attend:   Quality management systems are now, more than ever, a requirement rather than an option for sustainable businesses, both for increasing internal efficiency and for creating a competitive advantage. The easiest route for establishing a QMS is to base it on a proven method rather than starting from scratch. Medical device service providers, contract manufacturers, service providers and OEMs will benefit from implementing quality systems based on ISO 13485. The first part of the seminar will provide you with training on quality systems and the requirements of the revised standard. The second day will focus on developing a plan for implementation and will provide helpful tools you can take back to your organization to kick-start the project.   Areas Covered in the Session:   Gaining an understanding of the relationship between standards and quality management systems Understanding the basic principles of a quality management system Incorporating the Plan-Do-Check-Act approach Identifying the critical elements of a quality system Creating a documentation structure that is consistent with the system requirements Assessing and applying risk throughout the quality system Comparing the requirements of ISO 13485 to the FDA QSR Understanding the differences between ISO 9001, ISO 13485: 2003 and ISO 13485: 2016 Understanding the QMS requirements of the proposed EU Medical Device Regulation that are not in ISO 13485: 2016 Establishing a plan for implementing the revised requirements of ISO 13485: 2016   Who will benefit:   Executives, Directors, Senior Managers and Functional Managers from the Medical Device Industry with responsibilities in the following areas. We encourage the participation of more than one person from each company to facilitate the creation and implementation of your action plans. Quality associates Quality managers Document Control coordinators Project Managers Regulatory Affairs professionals Middle management in regulated industries Independent service organizations   Agenda:   Day 1 Schedule   Lecture 1: Anatomy of a Quality Management System Detailed review of all Clauses within the Standard Policies and Procedures designed to drive safety and compliance Supporting Documents and Databases covering operating procedures, staff training, and data management Operational Procedures guiding regulatory compliance, management involvement, and overall control of critical business functions Monitoring and measuring of quality processes and operational outcomes affecting product quality and patient safety Compliance and Improvement programs for audit, inspection, and clinical information Lecture 2: Gap Analysis of ISO 13485: 2003 to ISO 13485: 2016 Increasing efficiency, cutting costs, and monitoring supply chain performance through increased supplier controls Increased requirements for design control Covering new requirements for complaint handling, regulatory reporting and unique device identification Lecture 3: Application of Risk Ensuring all operational procedures are following a risk based approach Discussion of risk mitigation techniques and implementation Identifying ways to make medical devices safer and more effective   Day 2 Schedule   Lecture 1: Identification of Documentation Requirements Utilizing new Medical Device File requirements for each family or line of devices Reporting requirements to regulatory authorities Enhancing product design and development through validation and design transfer Preparing all necessary material for a Quality Report Lecture 2: Monitoring & Measurement of the QMS Validating software implementation into the manufacturing process and/or quality system Establishing evaluation procedures based on audit and quality reports Creating a system of checks and balances to analyze QMS success Lecture 3: Creating a Quality Plan for QMS Updates Obtaining senior leadership buy in to the new program Outlining how to review and improve processes across your organization Utilizing efficient reporting protocol and technology Identifying new or existing processes and documents affected by the changes Evaluating risks to the quality system associated with the QMS updates   Speaker Lena Cordie Quality & Regulatory Consultant, Qualitas Professional Services, LLC Lena Cordie has over 20 years of quality and project management experience including: 10 years in project management at Target Financial Services 11 years as Director of Operations at Key Surgical, a medical device company focused on sterile processing, personal protection, and OR products. In this position she was responsible for overseeing all quality and regulatory functions, production, product procurement, and order fulfillment. As a consultant at Qualitas Professional Services, LLC, Ms. Cordie now focuses on helping companies implement quality management systems, UDI solutions for labelling and FDA GUDID submissions, and providing validation, documentation and project management resources to global medical device companies. She is an active member of: AAMI (Association for the Advancement of Medical Instrumentation) - serves as a voting member of many sterilization standards committees and co-chairs the terminology committee ISO (International Organization for Standardization) - serves as a US representative and participates in ISO/TC 198 (ISO 17664 & ISO 11139) and ISO/TC 210 (ISO 13485 & ISO 15223) working groups RAPS (Regulatory Affairs Professionals Society) - serving as chairperson of the RAPS Twin Cities Chapter and a member of the RAPS EU Committee AHRMM Learning UDI Community   Location: Boston, MA Date:  March 1st & 2nd, 2018 and Time: 9AM to 6PM Venue:  Four Points by Sheraton Boston Logan Airport Revere, MA   407 Squire Rd, Revere, MA 02151, United States    Price: Register now and save $200. (Early Bird) Price: $1,495.00 (Seminar Fee for One Delegate) Register for 5 attendees   Price: $4,485.00 $6,475.00 You Save: $2,590.00 (40%)* Register for 10 attendees   Price: $8,222.00 $12,950.00 You Save: $5,828.00 (45%)*   Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar At 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. As 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. For More Information- https://www.globalcompliancepanel.com/control/sponsorship    Contact us today!   NetZealous LLC DBA GlobalCompliancePanel john.robinson@globalcompliancepanel.com   support@globalcompliancepanel.com  Toll free: +1-800-447-9407 Phone: +1-510-584-9661 Website: http://www.globalcompliancepanel.com   Registration Link - https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901585SEMINAR?eventbrite-March-2018-SEO Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/ Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/ Follow us on Twitter: https://twitter.com/GCPanel

When: Mar 1, 2018 9am in Revere, MA

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About Revere, MA
Revere Massachusetts is home of the famous Revere Beach which has been a destination location for many generations. The amusements are gone but the beauty of the beach is still available to everyone who visits.

Revere is a highly developed residential suburb located about 5 miles from downtown Boston. Almost 900 acres of Revere is open water and wetlands and the rest is used for residential-commercial and transportation purposes.

Revere is within a short distance to all major urban amenities including museum and medical facilities as well as theaters and institutions of higher learning and is even close by Logan International Airport. The city is convenient to Routes 1 as well as Route 93 and Route 128. With three public MBTA transportation systems-you can get anywhere in the world from Revere!

Revere Beach was the first public beach in the United States and is host to Wonderland Dog Racing Track and Suffolk Downs Horse Racing Track. Revere's multi-cultural and diverse population enjoys its residential neighborhoods and takes pride in its recently developed and improved extensive system of parks.