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Turkish Henna Night!
When: Mar 17, 2018 6pm 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 20, 2018 7pm to Mar 20, 2018 9pm in Revere, MA
Cost: $75.00 Members$95.00 Non-members

Complaint and Recall Management: A Compliant, Lean Program

Course "Complaint and Recall Management: A Compliant, Lean Program" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.   Overview: 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.   Location: Boston, MA Date:  March 22nd & 23rd, 2018 and Time: 9AM to 6PM Venue:  Four Points by Sheraton Boston Logan Airport Revere, MA   407 Squire Rd, Revere, MA 02151, United States Phone: +1 781-284-7200    Price: 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=901339SEMINAR?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 22, 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.