COURSE DESCRIPTION

OVERVIEW

This presentation is intended to expose the attendee to the challenges, opportunities, and best practices for performing remote internal and external good manufacturing practices (GMPs) compliance audits.

Audits are performed to assess compliance to standards, regulations, guidances, requirements, and specifications.  Audits are also critical in evaluating performance of processes and systems, gauging the adequacy and effectiveness of quality management systems, and determining conformance with contractual obligations.

When regional, national, or global issues like the recent COVID-19 pandemic restrict or otherwise prohibit travel, tradition on-site audits may not be an option, thus putting your organization at risk for compliance gaps and potentially jeopardizing the global supply chain.

Remote audits give your organization a viable alternative to ensure continued compliance with GMP requirements. Remote audits leverage modern technology to ensure workflows are efficient and accurate.  This course will teach you how to use those tools and show your firm’s continued commitment to GMP requirements.  This presentation will expose you to the challenges, opportunities, and best practices for performing remote internal and external good manufacturing practices (GMPs) compliance audits.

LEARNING OBJECTIVES

At the completion of this session, you will…

• Examine requirements for audits, and how they transfer to a remote setting
• Identify the principles of auditing
• Explore communication styles
• Determine technology requirements
• Identify linkages to risk
• Identify remote auditing challenges and opportunities
• Discuss remote audit program management
• Learn how to plan and perform remote audits
• Select audit documents and records
• Execute process approach audits