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.
Continue reading Section Meeting: What Does cGXP Mean And What Are The Differences Between cGLP, CGMP and cGCP?
In this month’s ASQ Member gift, we share resources around two systemic approaches to quality, past and present – Total Quality Management (TQM) and Integrated Management Systems (IMS.)
- Webcasts on integrated management systems and total quality management
- Complete e-book, Integrated Management Systems
- Complete handbook, Certified Manager of Quality/Organizational Excellence, Third Edition
- And much more!
Your exclusive member gift will be available through May 31, 2017.
Are you joining us for this month’s meeting? Register below for our first section meeting of 2017 where we will be discussing Smart Business Processes and the Future of Quality.
ISO 9001:2015 and Risk-Based Thinking
Changes introduced in the 2015 revision were made with the intention of ensuring that ISO 9001 continues to adapt to the changing environments in which organizations operate. One key update everyone is talking about is the emphasis on risk-based thinking.
In this gift ASQ shares lots of resources that will help you better understand and apply risk-based thinking through your ISO 9001:2015 transition and after to the benefit of your customers and organization.
Your exclusive member gift will be available through November 30, 2016.
The ISO 9001:2015 and Risk-Based Thinking bundle includes:
- New Webcast – ISO 9001:2015 – Elevating quality with risk- based thinking (50 minutes)
- Complete E-book – Lean ISO 9001: Adding spark to your ISO 9001 QMS and sustainability to your lean efforts (248 pp) and webcast (54 minutes)
- Eight articles on ISO and risk including – Running a Risk: A process for seeing decisions’ potential risks and adverse effects
- Nine Standards Channel expert videos on ISO 9001 and risk
- And much more!
39th Annual ASQ North Jersey Section “Spring Quality Training Conference” will be held on April 13th 2017.
Proposals will be reviewed by the Committee for relevance, innovation, demonstrated application, and technical content. Priority will be given to new and unique approaches that have resulted in measurable improvements to organizational processes and customer satisfaction. The following is a list of suggested topics; however, you are not limited to the list. Feel free to send proposals in all areas that you feel are relevant to this year’s theme “Quality Takes More Than Luck.”
Some Proposed Focus Areas:
- Leadership (Innovation, Change, Empowerment, Alignment to Goals)
- Auditing (Internal, External, 3rd Party, ISO, 16949, GMP)
- What’s New (Environmental, Regulatory, lessons learned etc.)
- Electronics (J-Standard, testing, inspecting, CEPM)
- FDA Regulated (Pharma, Medical Devices, Lessons Learned, Risk 14971)
- Lean and Six Sigma
Timeline Submit ASAP. The deadline for proposal submissions is September 30th, 2016.
Continue reading Call for Papers!! North New Jersey Spring 2017 Conference
This month’s section meeting will showcases several recent Lean Six Sigma projects, that the speaker facilitated, at local healthcare facilities where Lean Six Sigma Teams made processes faster, better and less expensive, while improving patient outcomes and satisfaction. The presentation will be interactive with comments and questions invited. Continue reading Section Meeting – Manufacturing Engineering Quality
Time and again research shows that one of the key prerequisites to successfully implementing quality programs and practices is buy-in of leadership. As a quality professional/practitioner it is imperative to effectively communicate the impact, risks, and financial costs of poor quality in a way that leadership will understand and be motivated by. From this need were born the concepts of cost of quality/cost of poor quality (CoQ/CoPQ).
In this gift we’ll get you started down the path of understanding and applying the principles and practices around CoQ/CoPQ, to both reveal opportunities for improvement and to better communicate the value and importance of quality, as it impacts the bottom line.
We include video introductions, webcast walkthroughs, articles, case studies, and not one but two completely free e-books on the topic. I know, it’s a lot of great info … our way of continuing to say thank you for being a part of the quality movement!
Your exclusive member gift will be available through August 31.
The Cost of Quality Bundle includes:
• The Cost of Quality (ASQ TV Episode)
• The Executive Guide to Understanding and Implementing Quality Cost Programs (e-book)
• The Hidden Factory (Webcast, 18 min.)
• An Introduction to the Cost of Quality (Webcast, 24 min.)
Mistake proofing or poka-yoke is the use of any automatic device or method that either makes it impossible for an error to occur or makes the error immediately obvious once it has occurred. Access the tool.