Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)

Duration: 120 Minutes
The key learning objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing Practices.
GMP vs GLP
Instructor: Angela K. Dunston
Product ID: 501255
Objectives of the Presentation
  • Gain insight into "Good Laboratory Practices" (21 CFR Part 58)
  • Learn what GLPs are and are not
  • Understand the basic elements of GLP
  • Learn about management responsibilities and "Sponsors"
  • Understand the Quality Assurance Unit Responsibilities
  • Understand the purpose of the study protocol and its importance in conducting acceptable studies
  • Determine the elements of a Final Report and why they are important
  • Compare and contrast all of the above GLP elements with Good Manufacturing Practice (GMP)
Why Should you Attend
A number of times there is industry confusion regarding the difference between GLPs and GMPs. 21 CFR Part 58 is not the equivalent of 21 CFR 210/211 and do not meet the same requirements as 210/211. They (Part 58) do have the force of law and are not "watered down" GMPs. Good Manufacturing Practice (cGMPs) represents that part of Quality Assurance that ensures the products are consistently produced and controlled to the Quality standard appropriate to their intended use and as required by the product specification. Non-clinical laboratory studies (58.1) support or are intended to support application for research or marketing permits for various products. GLPs do not include manufacturing product. Non-clinical Laboratory Studies (58.3) include in vitro or in vivo experiments in which test articles are studied prospectively in test systems under laboratory conditions to determine their safety. This does not include studies utilizing human subjects or clinical studies or field trials in animals.

Areas Covered
  • Introduction
  • Background
  • Comparisons between GLPs and GMPs
  • Differences between GLPs and GMPs
  • Major considerations between GLPs and GMPS
  • Questions and Answers
Who can Benefit
  • Quality Assurance personnel
  • Quality Control personnel
  • Research & Development
  • Regulatory Affairs Professionals
  • Project Managers
  • Auditing Professionals
  • Microbiology Professionals
  • Auditors
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Angela K. Dunston has over 20 years of experience in manufacturing and laboratory quality and compliance in the pharmaceutical, biotechnology, and medical device (diagnostics) industries. Her expertise is in defining, implementing, and maintaining Quality Management Systems that are cohesive and properly interact with all areas of the organization.

During these 20 years, Angela has actively participated in global regulatory inspections to include US FDA in the capacity of host, SME, and scribe. Through consulting with a variety of companies, Angela has worked with US FDA agents to ensure compliance for her clients.

The international experience obtained has assisted global organizations such as Johnson and Johnson, the Croda Corporation, Novartis, Hospira, Sanofi Pasteur, and Quintiles to exceed regulatory expectations. She has authored company best practices manuals and has trained on those procedures from the V-suite to the manufacturing floor. Angela works closely with the company’s staff to ensure a cohesive transition for non-compliance to policy approval.
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