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?
We have launched an the official LinkedIn company page to support the Section. Please follow the link below to join:
No? Well you still have plenty of time to register and attend these events:
For more information just click on the links above. Hope we see you at one of the events.
The 40th ASQ North Jersey Annual “Spring Quality Training Conference” March 29th, 2018 organized by the ASQ North Jersey Section 304
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.
Continue reading CALL for PAPERS!!!
There is still time to register for next week’s section meeting Healthcare Process Improvement – Early Sepsis Identification
Date & Time: June 13, 2017 from 6:30 – 8:30 PM
Location: Spanish Tavern 103 McWhorter Street – Newark, NJ 07105 (MapIt)
Continue reading Reminder: Are you attending next week’s Section Meeting?
Sepsis is associated with a high risk of mortality. The number of deaths in US due to sepsis has increased from 154,159 in 2000 to 207,427 in 2007. The main objective of this presentation is to demonstrate utilization of process improvement and system redesign methodologies for the purpose of improving broad spectrum antibiotics administration within 1 hour of severe sepsis/septic shock recognition, and studying its effect on mortality.
Continue reading June Section Meeting: Healthcare Process Improvement – Early Sepsis Identification
Great companies manage performance by looking at teams, not drudging through annual performance reviews. Agile Performance Management helps organizations understand how teams helping fulfill corporate goals and improve agile teams so that they can meet those goals. Social recognition and frequent feedback are the heart of agile. Skill development and just-in-time learning are investments that pay off. Measuring teams performance, providing feedback, and giving the tools to meet expectations – that’s what’s replacing tortuous annual performance reviews.
Agile Performance Management provides a full continuum of meaningful performance – and it happens all the time, not just every 6-months.
This presentation describes how organizations that have implemented the Agile Performance Management program can be successful in many ways:
• supporting a style of work that is collaborative, social and fast moving
• aligning the performance of teams with the goals of the organization
• providing employees with a voice in influencing individual, team and organizational performance
• providing supervisors with the skills they need to coach and counsel employees and teams every day, not just at annual appraisal times
• providing the organization with a health check of their training and organizational development efforts by gathering cumulative information about performance management trends
Continue reading May Section Meeting: Agile Performance Management