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.
Presented by: Nancy Sperling, MS QA/RA, Six Sigma Green Belt and CQA
Nancy is a Quality Assurance and Regulatory Compliance Professional. She has over 20 years of work experience which involved with pharmaceutical, biologics, medical devices, and consumer health products. Education includes and MS in Toxicology from St. John’s University and an MS in Quality Assurance and Regulatory Affairs from Temple University. Nancy believes in giving back to the community and volunteers for the following organizations: Fair Lawn Green Team, Environmental Commission, Gardening committee, mentored and instructed Middle school and High school students as per STEM as a volunteer of Students 2 Science and is an ACS volunteer career counselor.
DATE, TIME & PLACE: Wednesday, March 13, 2018, 6:30-8:30pm
Register for the Event (includes dinner)