Section Meeting

Section Meeting: What Does cGXP Mean And What Are The Differences Between cGLP, CGMP and cGCP?

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Many of us work in a regulated environment. We may work on the manufacturing floor of a pharmaceutical company or we may work in a clinical laboratory in a hospital. Many of us may work in a government laboratory or in an academic laboratory in a university. There is a common thread impacting all these settings which is known as cGXP. cGXP is a set of regulations which impact an organization to stay within compliance so as not to harm the public and result in closure of the institution. Within cGXP there are three categories which impact most workplaces and they are; cGMP, cGCP and cGLP. I will explain how these categories differ and the consequences that occur by not following these regulations. I am hoping that after this presentation, if you see something that is incorrect at your work place you will be able to cleverly point it out to your QA/compliance manager.

Whether it is in the laboratory, manufacturing floor or in the clinic there are regulatory requirements to be met. cGXP for the most part are the guiding regulations and there is confusion how these regulations differ. Please attend this meeting to find out.
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Section Meeting

Section Meeting: Got Risk? Risk Assessment Tools for ISO 14001: 2015

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In 2015, ISO 9001 was not the only management system standard revised to include risk and opportunities requirements. The latest revision of ISO 14001 also now includes risk and opportunity requirements for an environmental management system (EMS). But how can your EMS meet these requirements? Join us for a presentation of one company’s efforts to incorporate risk in the EMS. Specific discussion points include: developing and managing an EMS risk assessment process as part of a larger risk portfolio, risk tools and techniques adopted for determining environmental aspect significance, developing tools to include sustainability efforts in the EMS risk assessment process, and developing tools to communicate EMS risk assessment results to stakeholders.

Photo: Carl JohansenPRESENTED BY: Carl Johansen BSIT, MSTM, GRCP, GRCA, ISO 9001:2015 and ISO 14001:2015 Lead Auditor Certified, Section Manager Utility Shared Services Quality Management, Con Edison

In his current role at Con Edison Carl is the Section Manager for the Utility Shared Services Quality Management department and the program manager for the company-wide certification of its environmental management system to ISO 14001. Carl is applying quality management techniques honed in the manufacturing industry to the energy and utility sector at Con Edison. In his spare time, Carl is an automotive enthusiast who enjoys MINI Cooper rallies and shows with friends.

Carl is an active member of ASQ holding the marketing chair for the Design and Construction Division (DCD), the technology chair for the Customer-Supplier Division (CSD), and he’s a member of the environmental management sub-committee of ASQ’s Energy & Environment Division (EED) in the role of environmental management SME.
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Announcement, Chair, Event, NJIT Student Section, Section Meeting

2017 Annual Section Awards and Recognition Dinner

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The NY/NJ Metropolitan Section will be hosting it’s annual Holiday/Awards Dinner to recognize and thank those individuals who have worked so hard to plan and implement the Section’s events over the past year. Please come and join the celebration

Date: Saturday December 2nd at 6 PM to 10 PM

Location: APA Hotel Woodbridge, 120 S Wood Ave, Iselin, NJ 08830 (MapIt)

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Jobs

Quality Manager – New York City

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Infinite Consulting Corp (ICC), a program and construction management consulting firm, is in need of a full-time Quality Manager for a major New York City Transit station enhancement project.

The Quality Manager must possess the following qualifications:
• ISO 9000 or ASQ certified
• At least 5 years of experience
• Rail/transit experience preferred (particularly New York City Transit)

Interested candidates should send their resume and desired salary rate to pmok@infiniteconsultingcorp.com.

News

Member Leader Training Opportunity

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Greetings!

My name is David Levy. I am the elected Regional Director (RD) for Region 3. December 31, 2017 ends my term as RD. On January 1, 2018 Mike D’Onofrio, currently a Deputy RD (DRD) will take over as your new RD.

You may be wondering why I am telling you this. As a member of a section in Region 3 you should be aware that we serve your section in this elected position and your section leadership selected each of us for this position. Part of our role is representing you and your section on the Section Affairs Council (SAC) which established policies and practices for sections plus providing guidance in all that the section leaders do to serve you, the members.

Hopefully you are still with me. Both the RD role, and those of section leaders, is as a volunteer. ASQ refers to volunteers as Member Leaders. The RD position requires that we provide training to member leaders to help them understand their section roles and responsibilities and help deliver value to members.

Maybe you see where I’m going with this. Because member leaders are. . .members . . . we are inviting you, along with all current section member leaders to attend our annual Region 3 training, at no cost to you. So, whether you are a current section leader, considering becoming a section member leader, or had no clue, but are now interested in learning more, you are welcome to attend this event. Learn about ASQ, section operating requirements, and various roles in section leadership. Get a light breakfast, free lunch, snacks, and 0.8 re-certification units. Meet current leaders of your section. Network with other ASQ members in the region. It’ll be a good time.

Saturday, November 18, 2017
Registration: 8:00 AM – 8:30 AM
Program 8:30 AM – 4:00 PM
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Conference, Event, NJIT Student Section

ASQ NJIT Fall Ott Conference – October 9th, 2017

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Join us for the ASQ NJIT Fall Ott Conference on Visual Factory Management, Collaborative Robotics, Lean six-sigma Methods, Tools and Case Studies, organized by the NJIT ASQ Student Leadership Team: Michelle Vollo, President, Jovana Stijovic and Jelena Stijovic, Vice Presidents, Avery Bechtel, Program Chair, Philip Lelikov, Secretary, Terry Asante, Educational Chair, and Paul G Ranky, Founding Academic Advisor.

Several presenters will discuss Visual Factory Management, Collaborative Robotics, Lean six-sigma Methods, Tools and Case Studies in academia, as well as in industry. The core focus is Zero Defect Devices, Production, Service and Systems, including Root Cause Analysis (RCA). Root Cause Analysis is an essential first step when starting a six-sigma study for process improvement by controlling variations. RCA is generally applicable in situations where a defect occurs and there is a possibility that it might be beneficial to identify and address the real cause so that the situation does not occur again.

Every session will follow an interactive workshop style.

Event Date & Time: October 9, 2017, 6 to 9 pm

Location: NJIT (New Jersey Institute of Technology), Newark, NJ 07102, GITC building, room 2305

www.njit.edu (Parking is available, please email Dr Ranky: ranky@njit.edu well in advance; thanks!)
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