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Revere Massachusetts - Information and Local Business Directory

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☆░ ScapeOrNothing presents- Vybz By The Beach Each and every sunday ! ☆░
☆░ ScapeOrNothing Presents Vybz By The Beach each and every sunday Music by- #SoundsScape and Special guest DJ's Every Sunday.  Live grill, Serving carribbean food For Birthday Celebrations, Graduations and more contact- 857-205-7282, 617-510-5592 Venu- 63 Revere Beach BLVD, Revere MA-02151   ☆░ #Vybzbythebeach  #scapeornothing

When: Jul 15, 2018 4:30PM in Revere, MA

TMP EMPIRE- Diamond platnumz- Realman Rodriguez

When: Jul 15, 2018 7pm in Revere, MA

GxP/GMP and its Consequences for Quality Management, Quality Audit, Documentation, and Information Technology Systems

Course "GxP/GMP and its Consequences for Quality Management, Quality Audit, Documentation, and Information Technology Systems" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: GxP/GMP regulations are required to be used in regulated industries such as food and beverages, pharmaceutical, medical devices, and cosmetics. GMP regulations describe required quality management system for production and testing of products in these regulated industries. The purpose of the GMP regulations is to ensure that a product is safe and meets its intended use. Quality management system ensures that a product is safe and meets its intended use. Quality management system has four main components: quality planning, quality assurance, quality control, and quality improvement. Quality audit is the process of systematic inspection of quality management system which is carried out by an internal or external auditor or an audit team. It is an important part of organization's quality management system and is the major part of GxP/GMP regulations. CAPA - Corrective and Preventive Action plan. It is required for FDA compliance in case of specification situations or other deviations. Documentation is a critical tool for ensuring GxP/GMP compliance. In the regulated environment which must be GxP/GMP compliant, document control is the cornerstone of the quality system. It is so important that if an external audit identifies deficiencies in the document control system, the entire organization can be shut down. There are also GMP requirements for information technology. For a drug to be produced in a GxP/GMP compliant manner, some specific information technology practices must be followed. Computer systems involved in the development, manufacture, and sale of regulated product must meet certain requirements. Change control within quality management systems (QMS) and information technology (IT) systems is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. In the regulated industries, manufactures are required to use a change control procedure. In this seminar, you will learn the framework of GxP/GMP regulations, quality management system, quality audit, and CAPA. You will also learn the connection between GxP/GMP and document control, details of document control procedures and the role of Quality Assurance in the documentation systems. This seminar also includes very important GMP requirements for information technology and how computer systems including documentation management systems must meet GxP/GMP requirements. There is also a review of change control procedure and how it should be used in GxP/GMP environment. GMP regulations require that all documentation be issued, managed, and controlled using a document management system. This seminar also includes information about few major document management systems. Why you should attend: GxP/GMP is about Quality Management System (QMS) where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements. There are few types of quality audits. One of them is GMP audit. GMP audit is very important and critical for an organization in a regulated industry. The preparations for the audit should be done properly before the audit. The primary objective of the audit is to demonstrate the compliance with GxP/GMP regulations. In the regulated environment which must be GxP/GMP compliant, document control is the cornerstone of the quality system. It is so important that if an external audit identifies deficiencies in the document control system, the entire organization can be shut down. Documentation is the key to GMP compliance and ensures traceability of all development, manufacturing, and testing activities. Documentation provides the route for auditors to assess the overall quality of operations within a company and the final product. What is quality management system? Are you ready for the audit? Learn about GxP/GMP regulations and how they affect quality management system and quality audit. Learn about different types of quality audits and how to properly prepare for them, what actions you need to take to ensure that your organization will pass an audit. Do you know how to properly manage and control your documentation so that your organization can pass GMP audit? Are your IT systems GxP/GMP compliant? Learn how to manage and control documents as well as IT systems in compliance with GxP/GMP requirements and be able to pass quality audit. Who will benefit: Quality AssuranceDocumentation ManagersRecords ManagersDocument ControlComplianceMedical AffairsIT Agenda: Day 1 Schedule Lecture 1 (90 Mins):GxP/GMP Framework GxP/GMP, its Role, and its Consequences for the Regulated Industries Lecture 2 (90 Mins):Quality Management System and Quality Audit Quality Management SystemQuality Audit Lecture 3 (90 Mins):CAPA What is CAPA?CAPA ConceptsCAPA Procedure Lecture 4 (90 Mins):GxP/GMP and Documentation GxP/GMP and DocumentationPurpose of Document ControlControlled Documents - Types, IdentificationRole of QA in Document ControlDocument Control Procedures Day 2 Schedule Lecture 1 (90 Mins):GxP/GMP and IT Systems GxP/GMP Requirements for IT systems in regulated industriesIT Systems Validation Lecture 2 (90 Mins):Change Control Procedure GxP/GMP and Change Control ProcedureChange Control Procedure StepsChange Control Procedure for Document Control Lecture 3 (90 Mins):Change Control Procedure for Information Technology (IT) Systems IT Change Control Procedure Steps Lecture 4 (90 Mins):Document Management Systems SharePointArenaTeamSiteOpenTextOracle UCMSDL TridionOpen Source Systems Speaker Eleonora Babayants Founder and President, Galaxy Consulting Galaxy Consulting Founder and President Eleonora Babayants is a documentation management professional and hands-on consultant with over 25 years of experience in documentation and records management, document control, regulatory compliance, internal and external auditing, electronic document management systems, information governance, and change management. Location: Boston, MA Date: July 16th & 17th, 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: 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 10, Early Bird Price: $1,295.00 From June 11 to June 12, Regular Price: $1,495.00 Sponsorship Program benefits for Seminar For More Information- https://www.globalcompliancepanel.com/control/sponsorship Contact us today! NetZealous LLC DBA GlobalCompliancePanel john.robinson@globalcompliancepanel.com Toll free: +1-800-447-9407 Phone: +1-510-584-9661 Website: http://www.globalcompliancepanel.com Registration Link Follow 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 Seminar Fee for One Delegate - $1495.00 Register for 5 attendees - $4485.00 Register for 10 attendees - $8222.00

When: Jul 16, 2018 9am in Revere, MA
Cost: $1495.00 - $8222.00

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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.