COURSE DESCRIPTION

OVERVIEW

Keeping current and compliant with global health authority manufacturing mandates is based on understanding and implementing a set of “external GMP surveillance and influence” processes to ensure a GMP manufacturing facility remains compliant with the ever-changing “C” in current Good Manufacturing Processes (cGMP).  To maximize compliance and audit success, firms must take a “holistic” approach – blending training, an understanding of health authority expectations, and the implementation of a “Quality Knowledge System.”  This interactive session will provide you will the tools to get started.

This webinar is designed to educate attendees on how to design processes that can be used to determine what human health agencies around the world are looking for from law, guidance, and technical manufacturing perspectives.  We will cover the necessary steps to ensure CGMP compliance for pharmaceutical company manufacturing , contract manufacturing organizations (CMOs), and suppliers.  A Process Model will be proposed and discussed, including when and where to find important information.  Strategies will be discussed on the appropriate communication and archive methods for the outputs from the processes.  An important part of the process is ensuring all relevant information gets to the appropriate levels of the organization, and how it can be repurposed to use as GMP training.

Importantly, the concept of Quality Knowledge Management (QKM) will be introduced, and participants will learn the value of QKM to their organizations and how to build QKM processes based on organizational needs.  QKM is not an expensive technology investment.  A robust set of processes can be built using relatively simple tools that are probably already in-house.

LEARNING OBJECTIVES

At the completion of this session, you will be able to:

• Identify the importance of an external GMP surveillance and influence process to organization compliance
• Design and build a GMP surveillance process
• Package process output for individuals at different organization levels
• Repurpose the process output to produce GMP training
• Identify what a quality knowledge management system is, how it is used, and how it benefits the company