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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
Biostatistics for the Non-Statistician (ntz)
Biostatistics for the Non-Statistician (ntz)Thu, Mar 1, 2018, 9AM –Fri, Mar 2, 2018, 6PM ESTFour Points by Sheraton Boston Logan Airport Revere407 Squire Rd, RevereBoston, MA 02151United StatesDESCRIPTIONBiostatistics for the Non-StatisticianWhy should you attend:Statistics is a useful decision making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on development of a drug or procedure, it is imperative that decision makers understand the theory and application of statistics.Many statistical softwares are now available to professionals. However, these softwares were developed for statisticians and can often be daunting to non-statisticians. How do you know if you are pressing the right key, let alone performing the best test?This seminar provides a non-mathematical introduction to biostatistics and is designed for non-statisticians. And it will benefit professionals who must understand and work with study design and interpretation of findings in a clinical or biotechnology setting.The focus of the seminar is to give you the information and skills necessary to understand statistical concepts and findings as applies to clinical research, and to confidently convey the information to others.Emphasis will be placed on the actual statistical (a) concepts, (b) application, and (c) interpretation, and not on mathematical formulas or actual data analysis. A basic understanding of statistics is desired, but not necessary.Who will benefit:PhysiciansClinical Research AssociatesClinical Project Managers/LeadersSponsorsRegulatory Professionals who use statistical concepts/terminology in reportingMedical Writers who need to interpret statistical reportsDay 1 ScheduleLecture 1 (90 Mins):Why Statistics?Do we really need statistical tests?Sample vs. PopulationI'm a statistician not a magician! What statistics can and can't doDescriptive statistics and measures of variabilityLecture 2 (90 Mins):The many ways of interpretationConfidence intervalsp-valueseffect sizesClinical vs. meaningful significanceLecture 3 (90 Mins):Common Statistical TestsComparative testsRegression analysisNon-parametric techniquesLecture 4 (90 Mins):Bayesian LogicA different way of thinkingBayesian methods and statistical significanceBayesian applications to diagnostics testingBayesian applications to geneticsDay 2 ScheduleLecture 1 (90 Mins):Interpreting Statistics – Team ExerciseTeam Exercise: Review a scientific paper and learn how toInterpret statistical jargonLook for reproducibility, transparency, bias, and limitationsConvey information coherently to non-statisticiansLecture 2 (90 Mins):Study power and sample sizeReview of p-value, significance level, effect sizeFormulas, software, and other resources for computing a sample sizeLecture 3 (90 Mins):Developing a Statistical Analysis PlanUsing FDA guidance as a foundation, learn the steps and criteria needed to develop a statistical analysis plan (SAP).An SAP template will be given to all attendees.Lecture 4 (90 Mins):Specialized topics/Closing Comments/Q&AComparing Survival CurvesPharmocokinetics/Pharmacodynamics (PK/PD)Taking a holistic view to study design and interpretationQuestion and Answer session=========Speaker=========Elaine EisenbeiszOwner and Principal Statistician, Omega Statistics Elaine Eisenbeisz, is a private practice statistician and owner of Omega Statistics, a statistical consulting firm based in Southern California. Elaine has over 30 years of experience in creating data and information solutions for industries ranging from governmental agencies and corporations, to start-up companies and individual researchers.In addition to her technical expertise, Elaine possesses a talent for conveying statistical concepts and results in a way that people can intuitively understand.Elaine's love of numbers began in elementary school where she placed in regional and statewide mathematics competitions. She attended University of California, Riverside, as a National Science Foundation scholar, where she earned a B.S. in Statistics with a minor in Quantitative Management, Accounting. Elaine received her Master's Certification in Applied Statistcs from Texas A&M, and is currently finishing her graduate studies at Rochester Institute of Technology. Elaine is a member in good standing with the American Statistical Association as well as many other professional organizations. She is also a member of the Mensa High IQ Society. Omega Statistics holds an A+ rating with the Better Business Bureau.Elaine has designed the methodology for numerous studies in the clinical, biotech, and health care fields. She currently is an investigator on approximately 10 proton therapy clinical trials for Proton Collaborative Group, based in Illinois. She also designs and analyzes studies as a contract statistician for nutriceutical and fitness studies with QPS, a CRO based in Delaware. Elaine has also worked as a contract statistician with numerous private researchers and biotech start-ups as well as with larger companies such as Allergan and Rio Tinto Minerals. Not only is Elaine well versed in statistical methodology and analysis, she works well with project teams. Throughout her tenure as a private practice statistician, she has published work with researchers and colleagues in peer-reviewed journals. Please visit the Omega Statistics website at www.OmegaStatistics.com to learn more about Elaine and Omega Statistics.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 sposnsorships-----------------------------------------------------------------This event is brought to you by:NTZ - NewYorkEventsListhttp://www.NyEventsList.comhttp://www.BostonEventsList.comhttp://www.SFBayEventsList.com-----------------------------------------------------------------EDA180219EFUL

When: Mar 1, 2018 9am to Mar 1, 2018 6pm in Revere, MA
Cost: $1,285 – $7,112
ISO 13485:2016 Implementation Workshop (ntz)
ISO 13485:2016 Implementation Workshop (ntz)Thu, Mar 1, 2018, 9AM –Fri, Mar 2, 2018, 6PM ESTFour Points by Sheraton Boston Logan Airport Revere407 Squire Rd, RevereBoston, MA 02151United StatesDESCRIPTIONISO 13485:2016 Implementation WorkshopThe 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 systemsUnderstanding the basic principles of a quality management systemIncorporating the Plan-Do-Check-Act approachIdentifying the critical elements of a quality systemCreating a documentation structure that is consistent with the system requirementsAssessing and applying risk throughout the quality systemComparing the requirements of ISO 13485 to the FDA QSRUnderstanding the differences between ISO 9001, ISO 13485: 2003 and ISO 13485: 2016Understanding the QMS requirements of the proposed EU Medical Device Regulation that are not in ISO 13485: 2016Establishing a plan for implementing the revised requirements of ISO 13485: 2016Who 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 associatesQuality managersDocument Control coordinatorsProject ManagersRegulatory Affairs professionalsMiddle management in regulated industriesIndependent service organizationsDay 1 ScheduleLecture 1:Anatomy of a Quality Management SystemDetailed review of all Clauses within the StandardPolicies and Procedures designed to drive safety and complianceSupporting Documents and Databases covering operating procedures, staff training, and data managementOperational Procedures guiding regulatory compliance, management involvement, and overall control of critical business functionsMonitoring and measuring of quality processes and operational outcomes affecting product quality and patient safetyCompliance and Improvement programs for audit, inspection, and clinical informationLecture 2:Gap Analysis of ISO 13485: 2003 to ISO 13485: 2016Increasing efficiency, cutting costs, and monitoring supply chain performance through increased supplier controlsIncreased requirements for design controlCovering new requirements for complaint handling, regulatory reporting and unique device identificationLecture 3:Application of RiskEnsuring all operational procedures are following a risk based approachDiscussion of risk mitigation techniques and implementationIdentifying ways to make medical devices safer and more effectiveDay 2 ScheduleLecture 1:Identification of Documentation RequirementsUtilizing new Medical Device File requirements for each family or line of devicesReporting requirements to regulatory authoritiesEnhancing product design and development through validation and design transferPreparing all necessary material for a Quality ReportLecture 2:Monitoring & Measurement of the QMSValidating software implementation into the manufacturing process and/or quality systemEstablishing evaluation procedures based on audit and quality reportsCreating a system of checks and balances to analyze QMS successLecture 3:Creating a Quality Plan for QMS UpdatesObtaining senior leadership buy in to the new programOutlining how to review and improve processes across your organizationUtilizing efficient reporting protocol and technologyIdentifying new or existing processes and documents affected by the changesEvaluating risks to the quality system associated with the QMS updates========Speaker========Lena CordieQuality & 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 Services11 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 committeeISO (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 groupsRAPS (Regulatory Affairs Professionals Society) - serving as chairperson of the RAPS Twin Cities Chapter and a member of the RAPS EU CommitteeAHRMM Learning UDI CommunityPlease 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 sponsorship ----------------------------------------------------------------- This event is brought to you by: NetZealous LLC - NewYorkEventsList http://www.NyEventsList.com http://www.BostonEventsList.com http://www.SFBayEventsList.com -----------------------------------------------------------------EDA180219EFUL

When: Mar 1, 2018 9am to Mar 1, 2018 6pm in Revere, MA
Cost: $1,285 – $7,112
Validation and 21 CFR Part 11 Compliance of Computer Systems (ntz)
Validation and 21 CFR Part 11 Compliance of Computer Systems (ntz)Thu, Mar 1, 2018, 9AM –Fri, Mar 2, 2018, 6PM ESTFour Points by Sheraton Boston Logan Airport Revere407 Squire RdRevere, MA 02151United StatesDESCRIPTIONValidation and 21 CFR Part 11 Compliance of Computer SystemsComputer 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 ToolsThe SeminarThis 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 ValidationWho 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 ManagersIndustries:PharmaceuticalsBiotechMedical DeviceRadiological HealthBlood ProductsCompanion AnimalsFoodCosmeticsTobaccoAcademiaDay 1 ScheduleLecture 1: Introduction/BackgroundIntroductions / Participants' UnderstandingParticipants' Objectives for the Course (Please come prepared to discuss)Lecture 2: Requirements at a High LevelTypes of RequirementsDifference between User Requirements & Functional RequirementsLecture 3: Detailed Requirements StudyGathering RequirementsEntity Relationship DiagramProcess DecompositionRisk Assessment for RequirementsExercise on how to create RequirementsLecture 4: DesignDesign SpecificationsSoftware Configuration and BuildExercise on how to create Design SpecificationsDay 2 ScheduleLecture 5: CSV Detailed Study (Cont'd)Traceability MatrixVerification and TestingExercise Creating Validation ScriptsExercise Creating Traceability MatrixLecture 6: Other DocumentsValidation PlanTest ProtocolsTest ReportsValidation ReportValidation RegistryLecture 7: Special TopicsProject Management for CSVInfrastructure for CSVSelecting software for 21 CFR 11 ComplianceTest Tools for CSVLecture 8: Change Control & Business ContinuityChange ControlImplementing Business Continuity for CSV=========Speaker=========Angela BazigosCEO, Touchstone Technologies Silicon ValleySeasoned 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 sposnsorships-----------------------------------------------------------------This event is brought to you by:NTZ - NewYorkEventsListhttp://www.NyEventsList.comhttp://www.BostonEventsList.comhttp://www.SFBayEventsList.com-----------------------------------------------------------------EDA180219EFUL

When: Mar 1, 2018 9am to Mar 1, 2018 6pm in Revere, MA
Cost: $1,285 – $7,112
Different requirements for Phase I Investigational Drug Products (ntz)
Different requirements for Phase I Investigational Drug Products (ntz)Thu, Mar 1, 2018, 9AM –Fri, Mar 2, 2018, 6PM ESTFour Points by Sheraton Boston Logan Airport Revere, MA407 Squire Rd, RevereBoston, MA 02151United StatesDESCRIPTIONDifferent requirements for Phase I Investigational Drug Products: which GMPs apply since most Phase I drugs are exempt from full GMP requirements and what IND data requirements are necessary as a result?In January 2006, FDA issued a final rule which specified that most pharmaceutical products (including biologics) produced for use in Phase I clinical trial studies were exempted from complying with GMP requirements, as defined in 21 CFR Part 211 under 21 CFR 210.2(c). Section 501(a)(2)(B) of the FD&C Act requires drugs, including IND products, to comply with cGMPs or if they are not manufactured in compliance with cGMPs, they are deemed adulterated. Based on this statutory requirement for manufacturers to follow GMPs, FDA issued cGMP regulations for drug and biological products in the Code of Federal Regulations (in 21 CFR parts 210 and 211). There are certain requirements in 21 CFR Part 211 that are directed at the commercial manufacture of products typically characterized by large, repetitive, commercial batch production and requirements as a result, are not appropriate to the manufacture of most investigational drugs used for phase I clinical trials. Based on these issues, application of cGMPs to Phase I investigational drug products was exempted from 21 CFR 211. However, based on statutory requirements as given in Section 505(i) of the FD&C Act, FDA issued regulations governing IND products in order to protect human subjects enrolled in clinical trials, specifically with regards to the chemistry, manufacturing and controls data submitted as part of IND applications for drugs or biological products.Subsequent to FDAs final rule of January 2006, FDA released the Guidance for Industry, "INDs- Approaches to Complying with CGMP During Phase I". This document describes the CMC data necessary for inclusion in the IND. FDA reviews the IND to determine whether phase I investigational drugs to be used in the clinical trial to permit the trial to proceed, which is partially dependent on whether the product has the identity, strength, quality and purity and purported effect described in the IND application. FDA can chose to place the IND on clinical hold or could terminate the IND based on their review. If an IND is placed on clinical hold, the hold may be removed if the sponsor addresses the deficiencies, but clinical trials may not progress until the clinical hold is removed.In July 2008, FDA issued an additional Guidance for Industry, "CGMP for Phase I Investigational Drugs", in order to provide guidance to sponsors regarding meeting GMPs appropriate for Phase I investigational drug products. In this seminar, the attendees will gain a complete understanding of all current good manufacturing practices that are applicable to the manufacture of Phase I investigational drug product, in addition to understanding which products were exempt and which were not. The attendees will gain an understanding of CMC data necessary for the preparation of an Investigational New Drug application, and have an understanding of the requirements of the document and therefore avoid clinical holds or termination of the IND. Additionally, based on the products that were exempted from GMPs as defined in 21 CFR part 211, several guidance documents were created to provide guidance regarding the content and format of the CMC information necessary for inclusion in the IND for the following products: for Phase I, studies of drugs, including well-characterized, therapeutic, biotechnology-derived products, for somatic cellular therapy and for human gene therapy INDs.Why should you attend:FDAs guidance document "Good Manufacturing Practice for Phase I Investigational Drug Products" applies to correct GMP requirements to drug products made for the purpose of using an investigational drug product on human subjects for the first time, during conduct of Phase I clinical trials, which can begin if your IND is not put on clinical hold in 30 days after receipt by the FDA. If they review your IND and the appropriate information is not available to ensure FDA of the quality of the product, the IND will be placed on clinical hold, preventing your clinical program from going forward. The necessary content of the IND will not be discussed in this webinar, but the specific GMPs for Phase I Investigational drugs will be understood by attendees, therefore allowing the applicant to apply only those GMPs which are applicable to the drug product at this stage of development, instead of trying to apply GMPs, as defined in 21 CFR Part 211, to Phase I Investigational drug products, which often leads to frustration and even errors, as the CFR definition was meant for commercial batches, which are large and repetitive, as well as different in other ways, making the application of some of the GMPs for finished drug products impossible.Who will benefit:Quality Associates or SpecialistsRegulatory Management or Regulatory SpecialistsCompliance professionalsQuality AuditorsValidation EngineersR & D Scientists- chemists, geneticists, biochemistry specialists, formulation chemistryLaboratory PersonnelSenior Quality Managers, Quality VPsDay 1 ScheduleLecture 1 (90 Mins):30 Minutes: brief overview of the objectives of the seminar, brief introduction of attendees, including their functions, type of products that they are working on (if applicable), and the function(s) they serve.60 Minutes: an explanation of the statutory requirements, the changes that precipitated the products being exempt and the specific products exempt and those that were not exempt will be discussed.Lecture 2 (90 Mins):Brief discussion of the product lifecycle, including when regulatory filings, such as the IND and NDA (or the equivalent, depending on region) are filed, description of differences in chemically-synthesized drug and biologic products and biotech products will be briefly discussed. Brief discussion of the Pharmaceutical Quality System, as per ICH Q10 (and the companion documents, ICH Q8, pharmaceutical development and ICH Q9, quality risk management, will be introduced.Lecture 3 (90 Mins):15-30 Minutes: brief discussion of GMPs for APIs, specifically the information that addresses GMPs for products in clinical trials, ICH Q7. GMPs for phase I investigational drug products will be dsicussed, including guidance for complying with the statute, discussion of having appropriate QC procedures in effect during product development to ensure the quality and safety of the investigational drugs are maintained, as well as emphasis on following appropriate GMPs, as both of these actions will facilitate the manufacture of equivalent of comparable IND product for future clinical trials. Several different resources/technologies are suggested to facilitate conformance with cGMPs and to streamline product development.Lecture 4 (90 Mins):Additional review of GMPs for phase I investigational drug products, including personnnel, QC function, facility and equipment, control of components, and containers and closures, manufacturing and records, laboratory controls, including testing and stabilit, packaging, labeling and distributing and recordkeeping will be addressed. If we do not get through all of the information just mentioned in this time period, the dicussion will continue the following day, along with the remaining content that needs to be understood for implementing GMPs for Phase I Products.Day 2 ScheduleLecture 1 (90 Mins):Continued discussion of GMPs for Phase I Investigational drug products, including content from previous day and the special manufacturing situations, such as multi-product facilities.Lecture 2 (90 Mins):Continued discussion of GMPs for Phase I Investigational drug products to include considerations and adventitious agent control will be addressed in regards to biological and biotechnological products. Gene therapy and cellular therapy products will be addressed, as well as sterile products/aseptically processed products. The remaining time will introduce "INDs - Approaches to complying with CGMP during Phase I".Lecture 3 (90 Mins):The IND Regulation(21 CFR 312.23(a)(7)(i)) will be reviewed, including the "sufficient CMC information to ensure the proper identification, quality, purity, and strength of the investigational drug." Each item (identification, quality, purity, and strength of the investigational drug) will be reviewed, including meaning of each, some of the requirements, such as strength and assays for drug substance and drug product, validation requirements of each, blend uniformity, uniformity of dosage units, container/closure, stability, etc. If additional time is left, will start review of CMC regulatory requirements.Lecture 4 (90 Mins):The CMC regulatory requirements, including requirements for drug substance (APIs) and drug products. Potential safety concerns for an investigational drug product (and its' drug substance) will be discussed in order to help attendees avoid safety issues and clinical holds. Other potential hold issues will be addressed, including impurities, expiration dating, etc. will be addressed. The ICH guidance documents specific for identity, stability, etc. will be provided to the attendees. Questions will be accepted throughout the seminar, but any questions that the attendees have and discussions are encouraged to ensure that all attendees have any questions answered.========Speaker========Stephanie CookePresident/CEO, Cooke Consulting Inc. Stephanie Cooke, is the President/CEO of Cooke Consulting, Inc. Stephanie uses her roughly 20 years of experience to provide global consulting services in various areas of Regulatory Affairs, Quality Assurance and validation for pharmaceutical, biological/biotech products, medical device, combination drug/device and nutraceutical firms. Her broad-based experience includes preparation of regulatory dossiers for human and animal pharmaceutical (chemical entities and biologically-based drugs), biotech products, drug/device combination products and medical devices in all stages of development (INDs, NDAs, BLAs, post-marketing supplements such as CBEs, Prior approval supplements, orphan drug designation and related submissions, 510ks, PMAs and HDEs). She also has extensive QA and validation experience, successfully hosting many regulatory audits conducted by FDA, ISO and other international regulatory bodies (Irish Medical Board and others), training personnel on hosting audits by global regulatory bodies, as well as establishing auditing programs to qualify contract manufacturers and vendors of raw materials, APIs, etc. and product release experience in manufacturing environments and for companies using contract manufacturers, responsibility for establishing and maintaining Quality systems for all product types, establishing stability programs, as well as preparation/performance of process validation(s), including sterilization validation(s) (EtO, steam, gamma), aseptic processing, qualification of cleanrooms/water systems and manufacturing process validation. Stephanie has been involved in the development of drugs, including biologics, biotech products and medical devices, from product concept through post-approval maintenance including requirements for submissions for various regions/countries, process validation requirements, etc. and has considerable project management experience. Ms. Cooke is experienced the development of APIs, drug products (including biological/biotech products and their associated manufacturing processes. In addition, she has had much experience working on CMC sections of the CTD for various countries/regions, establishing required preclinical and clinical testing necessary for regulatory filings, as well as preparing the information for regulatory submissions. Prior to beginning Cooke Consulting, Inc.about 9 years ago, Stephanie worked for Sciele - Pharma from 2005-2009 as the VP of Regulatory Affairs, Quality Assurance/Validation. She also held various senior RA, QA and validation positions at Merial, Bayer (Visible Genetics), Cryolife, Theragenics and other pharmaceutical, biotech and medical device companies, after beginning in industry as a lab tech and working as a certified as a Microbiologist. She has a BS in Biology and an M.S. in Molecular Genetics and Biochemistry from Georgia State University.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 sposnsorships-----------------------------------------------------------------This event is brought to you by:NTZ - NewYorkEventsListhttp://www.NyEventsList.comhttp://www.BostonEventsList.comhttp://www.SFBayEventsList.com-----------------------------------------------------------------EDA180219EFUL

When: Mar 1, 2018 9am to Mar 1, 2018 6pm in Revere, MA
Cost: $1,285 – $7,112
Wildlife Garden Team
Sponsored by: MA Department of Conservation and Recreation
Minimum age: 18
Gardeners of East Boston (and surrounding neighborhoods) wanted! We are planning to plant wildflowers, grasses, trees, and shrubs to benefit native birds, bees, butterflies, and moths at DCR’s Belle Isle Marsh Reservation in East Boston, based on preferences of local residents. Come to our first p . . .

When: Mar 3, 2018 10am in Revere, MA
Crash Course in Judaism
Uncover Judaism’s most inspiring ideas and explore your spirituality in our 10-week course.For 10 weeks—one class per week for a duration of 2 hours—we hold our “Crash Course: Judaism” adult education program. As an introduction, or, for some, a reintroduction, to Judaism course, we will explore the accessible and thought-provoking questions of a 3,000-year-old tradition. For those unsure about a return to the basics, do not fret as we will delve deep beneath the surface.We welcome non-Jews and Jews alike. For those who are not yet Jewish and have always been a little bit curious, we hope to see you around the table. For those sharing their lives with Jews and wanting to learn more about their culture, we want to hear from you. Whether you were born Jewish but never quite learned what it was about, you’re back after a long hiatus, or you’re just looking for a deeper understanding of your heritage, we could all use a bit of a refresher.Classes cover Judaism’s biggest and most inspiring ideas as well as the nuts and bolts of daily Jewish living. We will cover history, holidays, practices, text and values. In addition, we’ll dedicate time in each class to the Aleph-Bet (Hebrew alphabet) and, depending on your background, either teach you to read Hebrew or help you brush up on your Hebrew skills.The course runs Tuesday nights from 3/6 to 5/15 (no class on 3/27).

When: Mar 6, 2018 7pm to Mar 6, 2018 9pm in Revere, MA
Cost: $75.00 Members$95.00 Non-members
Showcase Cinemas’ 10 Days of Event Cinema Presents Sixteen Candles

Showcase Cinemas presents 10 Days of Event Cinema featuring Sixteen Candles! Take a trip back to your years of teenage angst and watch as Samantha’s sixteenth birthday becomes anything but special as she suffers from every embarrassment possible. Catch the classic Molly Ringwald film on March 8th. Purchase your tickets now at:

https://www.showcasecinemas.com/movie/sixteen-candles



When: Mar 8, 2018 7:30PM in Revere, MA
Cost: $10