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Clinical Data Management
Course "Clinical Data Management" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.Overview:When new drugs or devices are tested in humans, the data generated by, and related to, these trials is known as clinical data. This data represents a huge investment by the biopharmaceutical or device company and is one of its greatest assets. It is this data that will eventually make a new product both useful as a treatment or therapy and marketable. The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. As its importance has grown, clinical data management (CDM) has changed from an essentially clerical task in the late 1970s and early 1980s to the highly computerized specialty it is today.This seminar is based on the current state of regulations and will cover the essential parts of the data management plan, study startup, study conduct, study closeout and study monitoring.A data management plan or DMP is a formal document that outlines how data are to be handled both during a research project, and after the project is completed. The goal of a data management plan is to consider the many aspects of data management, metadata generation, data preservation, and analysis before the project begins; this ensures that data are well-managed in the present, and prepared for preservation in the future.Study startup activities include designing case report forms (CRFs), paper or computer; specifying cleaning rules (edit checks); building and testing the database; and releasing the study database to collect data.Study conduct activities include collecting the data on CRFs and via electronic files, cleaning that data, managing adverse event and serious adverse event collection, and producing reports.Study closeout focuses on ensuring the data is complete and of a quality to support final analysis.Study monitoring is an in-person evaluation carried out by sponsor personnel or representatives at the sites at which the clinical investigation is being conducted. On-site monitoring can identify data entry errors (e.g., discrepancies between source records and case report forms (CRFs)) and missing data in source records or CRFs; and assess compliance with the protocol and investigational product________________________________________At the end of this class attendees will be able to:• Define best practices as they apply to CDM processes• Describe CDM processes from study start-up to database lock• Apply best practice rationale when assessing data collection requirements/instruments• Evaluate the benefits of standardization in establishing CDM processes• Discuss current technology/methods of data collection and associated documentation________________________________________Who Will Benefit:• New or aspiring Clinical Data Managers• Clinical Data Managers• Data Coordinators• Clinical Research Associates• Data Management Personnel• Biostatisticians• Regulators• Doctors• Nurses• Project Managers• Government employees at clinicaltrials.gov• College Students and New Graduates in a Scientific Field• This course is also ideal for "on-boarding" of individual new hires or entire teamsAgenda:Day 1 Schedule________________________________________Lecture 1 (90 Mins):CDM: The Reasons and The Requirements• GIGO = Garbage In, Garbage Out. Why we need good practices in data management• Presentation and overview of FDA GCP Guidelines on data management• NIH Policy (SOP 15, 17, 19)• 21 CFR Parts 11, 312.62, 812.140,________________________________________Lecture 2 (90 Mins):Elements in Developing a Data Management Plan• Choosing vendors and outsourcing• Data privacy and protection of subject data• Quality Assurance and Quality Control• Monitoring and auditing of data• Handling Errors and Corrections• Storage and Transfer of Data________________________________________Lecture 3 (180 Mins):Study Startup• Essential documentso Prior to Study Commencemento During Conduct of the Trialo After Completion/Termination of the Trial• CRF design and development (paper/e-CRF)• Database build and testing• Edit Checks preparation and testingDay 2 Schedule________________________________________Lecture 1 (90 Mins):Study Conduct• Data Entry• External Data integration and reconciliation• Discrepancies, errors, corrections• Data Cleaning (preparation) and Coding________________________________________Lecture 2 (90 Mins):Study Conduct (cont'd)• (MedDRA and WHODDE dictionaries)• Severe adverse events (SAE) status reporting• Data Review and Quality Control• Data Transfer procedures________________________________________Lecture 3 (90 Mins):Study Closeout• SAE Reconciliation• Quality Control• Database Lock• Electronic Archival• Database Transfer• Enhancing Reproducibility________________________________________Lecture 4 (90 Mins):Monitoring Visits• What to expect during a monitoring visit• Elements for Establishing a Corrective Action Plan• Jeopardy Quiz - Clinical Data ManagementSpeakerAngela BazigosCEO, Touchstone Technologies Silicon Valley Angela Bazigos is the CEO of Touchstone Technologies Inc. and has 40 years of experience in the Life Sciences, Healthcare & Public Health Services. She has extensive experience in Computer Systems Validation and Data Integrity including having collaborated with FDA on prototyping 21 CFR 11 in 1992-1995, patent on using virtualization to speed up validation and a book on computerized systems in clinical research co-authored with FDA and DIA . She has successfully completed 56 large validation projects with a 94% on-time / on budget record.Location: Boston, MA Date: July 26th & 27th, 2018 and Time: 9AM to 6PMVenue: WILL BE ANNOUNCED SOONPrice:Price: $1,295.00 (Seminar Fee for One Delegate) 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%)* Register now and save $200. (Early Bird)Until June 20, Early Bird Price: $1,295.00 From June 21 to July 24, Regular Price: $1,495.00Sponsorship Program benefits for seminarFor More Information- https://www.globalcompliancepanel.com/control/sponsorship Contact us today!NetZealous LLC DBA GlobalCompliancePaneljohn.robinson@globalcompliancepanel.com Toll free: +1-800-447-9407Phone: +1-510-584-9661 Website: http://www.globalcompliancepanel.comRegistration Link - https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901825SEMINAR?SEOFollow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanelindia/ Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/Follow us on Twitter: https://twitter.com/GCPanel

When: Jul 26, 2018 9am to Jul 26, 2018 6pm in Revere, MA
Cost: Price:Price: $1,295.00 (Seminar Fee for One Delegate) 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%)* Register now and save $200. (Early Bird)Until June 20, Early Bird Price: $1,295.00 From June 21 to July 24, Regular Price: $1,495.00

Complaint and Recall Management: A Compliant, Lean Program (NTZ)

Complaint and Recall Management: A Compliant, Lean Program *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY!  Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved in the corrective action, and Quality Engineering may need to trend the complaints! This session will include the requirements for all of the above responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications. Also covered will be a discussion of what constitutes a complaint, and recommended practice on how to handle "non-complaint" feedback. Attention will be paid to the application of risk management to a complaint handling system, and a specific risk management system explained. Learning Objectives: This seminar contains a streamlined review of the regulations, allowing the majority of time to be spent on a detailed focus on critical process requirements for compliance with the regulations. Jeff will also call from his 30+ years of experience in this area to put forth recommendations for methods of documentation that are straightforward and compliant. Among these recommendations are contents of complaint records, root cause investigations, and corrective actions. This seminar also covers the application of risk management principles to complaint investigation Why you should attend: Complaint Handling is one of the more cross-functional aspects of your QMS, not to mention it being clearly the most customer-facing. To that end, many different functions will benefit from this presentation: Customer Service (your "complaint taker") Regulatory personnel Quality Engineering personnel Sales and Marketing personnel Customer Service personnel R&D personnel Manufacturing Engineering Executive Management Consultants Quality system auditors AGENDA  Day 1 Schedule Lecture 1: Introduction Lecture 2: Complaint Handling Regulatory Overview: FDA, ISO 13485 (including 13485:2016) Definitions Application of Definitions The Value of "Non-complaints" Complaint Triage and Handling Complaint Investigations "Closing" Complaints Contents of Complaint Form Complaint Review and Trending Implementation of Risk Management into Complaint Handling Common Pitfalls and How to Overcome Them Exercise: Complaint or Non-complaint? Day 2 Schedule Lecture 1: Adverse Event Reporting Regulatory Overview: FDA, MDD MDRs Reporting Process Reporting Requirements Vigilance Reports Reporting Process Reporting Requirements Exercise: Reportability of Events Lecture 2: Recalls / Field Corrective Actions Regulatory Overview: FDA, MEDDEV, Health Canada FDA Regulations EU Requirements Competent Authority Reportable Event Reporting Requirements Corrections and Removals Market Withdrawal and Stock Recovery Recall Classifications Roles and Responsibilities Lecture 3: Q&A - Conclusion SPEAKER Jeff Kasoff Director of Regulatory Affairs, Life-Tech, Inc Jeff Kasoff, RAC, CMQ/OE, LBB is the Principal Consultant at Lean to Quality, LLC. He has more than 30 years of experience in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from start-up to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff received his Regulatory Affairs Certification from RAPS, his Manager of Quality and Organizational Excellence certification from ASQ, and his Lean Black Belt from IIE. Please contact the event manager Marilyn (marilyn.b.turner@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 sponsorshipsNO REFUNDS ALLOWED ON REGISTRATIONSService fees included in this listing.-----------------------------------------------------------------This event is brought to you by:Netzealous LLC - NewYorkEventsListhttp://www.NyEventsList.comhttp://www.BostonEventsList.comhttp://www.SFBayEventsList.com-----------------------------------------------------------------MYL180527CEV MYL180614CHK

When: Jul 26, 2018 9am in Revere, MA

Clinical Data Management (NTZ)

Clinical Data Management *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! ***REGISTER TODAY! When new drugs or devices are tested in humans, the data generated by, and related to, these trials is known as clinical data. This data represents a huge investment by the biopharmaceutical or device company and is one of its greatest assets. It is this data that will eventually make a new product both useful as a treatment or therapy and marketable. The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. As its importance has grown, clinical data management (CDM) has changed from an essentially clerical task in the late 1970s and early 1980s to the highly computerized specialty it is today. This seminar is based on the current state of regulations and will cover the essential parts of the data management plan, study startup, study conduct, study closeout and study monitoring. A data management plan or DMP is a formal document that outlines how data are to be handled both during a research project, and after the project is completed. The goal of a data management plan is to consider the many aspects of data management, metadata generation, data preservation, and analysis before the project begins; this ensures that data are well-managed in the present, and prepared for preservation in the future. Study startup activities include designing case report forms (CRFs), paper or computer; specifying cleaning rules (edit checks); building and testing the database; and releasing the study database to collect data. Study conduct activities include collecting the data on CRFs and via electronic files, cleaning that data, managing adverse event and serious adverse event collection, and producing reports. Study closeout focuses on ensuring the data is complete and of a quality to support final analysis. Study monitoring is an in-person evaluation carried out by sponsor personnel or representatives at the sites at which the clinical investigation is being conducted. On-site monitoring can identify data entry errors (e.g., discrepancies between source records and case report forms (CRFs)) and missing data in source records or CRFs; and assess compliance with the protocol and investigational product At the end of this class attendees will be able to: Define best practices as they apply to CDM processes Describe CDM processes from study start-up to database lock Apply best practice rationale when assessing data collection requirements/instruments Evaluate the benefits of standardization in establishing CDM processes Discuss current technology/methods of data collection and associated documentation Who Will Benefit: New or aspiring Clinical Data Managers Clinical Data Managers Data Coordinators Clinical Research Associates Data Management Personnel Biostatisticians Regulators Doctors Nurses Project Managers Government employees at clinicaltrials.gov College Students and New Graduates in a Scientific Field This course is also ideal for "on-boarding" of individual new hires or entire teams AGENDA Day 1 Schedule Lecture 1 (90 Mins): CDM: The Reasons and The Requirements GIGO = Garbage In, Garbage Out. Why we need good practices in data management Presentation and overview of FDA GCP Guidelines on data management NIH Policy (SOP 15, 17, 19) 21 CFR Parts 11, 312.62, 812.140, Lecture 2 (90 Mins): Elements in Developing a Data Management Plan Choosing vendors and outsourcing Data privacy and protection of subject data Quality Assurance and Quality Control Monitoring and auditing of data Handling Errors and Corrections Storage and Transfer of Data Lecture 3 (180 Mins): Study Startup Essential documents Prior to Study Commencement During Conduct of the Trial After Completion/Termination of the Trial CRF design and development (paper/e-CRF) Database build and testing Edit Checks preparation and testing Day 2 Schedule Lecture 1 (90 Mins): Study Conduct Data Entry External Data integration and reconciliation Discrepancies, errors, corrections Data Cleaning (preparation) and Coding Lecture 2 (90 Mins): Study Conduct (cont'd) (MedDRA and WHODDE dictionaries) Severe adverse events (SAE) status reporting Data Review and Quality Control Data Transfer procedures Lecture 3 (90 Mins): Study Closeout SAE Reconciliation Quality Control Database Lock Electronic Archival Database Transfer Enhancing Reproducibility Lecture 4 (90 Mins): Monitoring Visits What to expect during a monitoring visit Elements for Establishing a Corrective Action Plan Jeopardy Quiz - Clinical Data Management SPEAKER Angela Bazigos CEO, Touchstone Technologies Silicon Valley Angela Bazigos is the CEO of Touchstone Technologies Inc. and has 40 years of experience in the Life Sciences, Healthcare & Public Health Services. She has extensive experience in Computer Systems Validation and Data Integrity including having collaborated with FDA on prototyping 21 CFR 11 in 1992-1995, patent on using virtualization to speed up validation and a book on computerized systems in clinical research co-authored with FDA and DIA . She has successfully completed 56 large validation projects with a 94% on-time / on budget record. Ms. Bazigos has degrees in Microbiology and Computing which she has used for her wide experience. Her experience includes Quality Assurance, Regulatory Compliance, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer , Director of QA and MIS Director. Interviewed by Wall Street Journal on using training to bring regulatory compliance to the Boardroom . Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford's Who's Who for LifeSciences :. Please contact the event manager Marilyn (marilyn.b.turner@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 sponsorshipsNO REFUNDS ALLOWED ON REGISTRATIONSService fees included in this listing.-----------------------------------------------------------------This event is brought to you by:Netzealous LLC. - NewYorkEventsListhttp://www.NyEventsList.comhttp://www.BostonEventsList.comhttp://www.SFBayEventsList.com-----------------------------------------------------------------MYL180515CEV MYL180527UPD

When: Jul 26, 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.