6-Hour Virtual Seminar on GxP and the Quality System

GxP is the heart and soul of how we do business in regulated industries. GxP is a general abbreviation for the “good practice” quality guidelines and regulations. The “x” in the term stands for the various aspects of good practice that are essential to the operation of a compliant organization.

What exactly are Good “x” Practices? This all-encompassing term, GxP, actually includes GAO – Good Agricultural Practice, GMP – Good Manufacturing Practice, GLP – Good Laboratory Practice, GSP – Good Supply Practice and GDP – Good Distribution Practice. They each are a set of practices that comply with regulations and industry standards that ensure that your products are as effective as claimed and are pure and defect free throughout their entire lifecycle.

Every country to include the US through the FDA has their own set of governing GxP regulations. Some of these practices are harmonized with others while some are not. They are not guidelines…they have the weight of law. They essentially dictate how every aspect of product development, production, and distribution is executed.

The purpose of these regulations? It is very simple – to ensure that foods, medical devices, medicinal products are safe and effective. Achieving this safety and effectiveness requirement however is not so simple. It is achieved by implementing what is known as a Quality System consisting of many regulatory requirements as specified in the governing regulations that must be:

  • Documented in the form of Standard Operating Procedures and Work Instructions
  • Integrated into the fabric of how the business executes the activities required to place a medical/medicinal product into the marketplace
  • Be managed on a daily basis to ensure the organization’s compliance to the tenants of the regulation
  • Be provable when externally audited to verify its effectiveness and compliance with the regulation

How do GxP’s relate to the Quality System? The quality system documents all of the policies, processes, procedures, and assigned responsibilities that are required for the organization to be compliant and meet all of their regulatory responsibilities. The Quality System is the bridge between all of the relevant GxP regulations and the reality of the operation.

Why You Should Attend:

This virtual seminar will examine all of key aspects of this subject as it relates and can contribute to efficient, effective, and compliant operations. Topics such as Complaint Handling and CAPA, documentation and documentation control and the role they play, and change control will be addressed during the 6-hour presentation. The quality system itself will also be discussed in terms of its critical importance, its contents, and its structure.

If you work within the life sciences or even the food industry, almost everything that you do every day is somehow touched by GxP practices. Ignorance of their importance, their application to what you do, and how they govern each facet of your product’s lifecycle is no excuse for non-compliance. It takes a complete thorough understanding to ensure your compliance. This virtual seminar will provide that level of understanding and some basic guidance to assure compliance. FDB3388

Charles Paul is an instructional designer and management consultant with over 30 years’ experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product – OTC industries.

Learning Objectives:

  • Define GxP and state why it is important to life sciences operations
  • List and describe the practices that comprise GxP
  • Discuss the federal regulations that apply to each practice
  • Explain the purpose of the quality system, how it is structured, and how it is vital to effective product development, production, and retirement.
  • Explain how quality audits are prepared for and managed
  • Explain the importance of complaint handling and CAPA to patient safety
  • Discuss how compliance documentation ties all of the processes and practices together and serves not only to meet regulatory requirements but to also support training and actual human performance.
  • Explain the importance of the concept of change control in terms of how it is governed, managed and executed

Areas Covered in the Session:

  • What is GxP and why is it important?
  • The GxP components – GAP, GMP, GLP, GSP and GDP
  • Applicable federal regulations
  • The quality system – why it is important and its components
  • Preparing for quality audits
  • Complaint handling and CAPA and why they are important
  • Compliance Documentation – its importance and its management and its applicability to operational effectiveness as well as compliance
  • Change control the concept and execution
  • Quality Assurance Departments
  • Quality Control Departments
  • Research and Development Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Validation Departments
  • Marketing Departments
  • Compliance Departments
  • Supply Chain and Logistics Departments
  • IT Departments
  • Documentation Departments
  • Training Departments
  • Packaging Departments
  • Maintenance Departments
  • Scientists
  • Laboratory Personnel
  • Everyone in Lifesciences involved with GxP and Quality Systems

membership
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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance