Mastering Compliance and Operational Excellence in FDA-regulated Industries: Systems-based Approach to Internal Audits

Life Sciences, Pharmaceutical Regulation, Pharmaceutical,
  • Thursday, January 16, 2025 | 2pm EST / 1pm CST / 11am PST
  • 60 min

Discover an informative webinar focusing on a systems-based approach to internal audits, a method embraced by regulatory inspectors worldwide, designed to streamline compliance and boost operational efficiency.

In this webinar, which will help FDA-regulated professionals enhance their auditing processes, the expert speakers will discuss the following topics:

  • An understanding of the six-systems approach utilized by regulatory inspectors
  • The tangible benefits of adopting a systems-based model in organizations
  • Practical tips and tools to implement a systems-based internal auditing program effectively

The speakers will provide real-life case studies that illustrate the positive impacts of this approach and provide a valuable opportunity for learning and growth. The attendees will gain insights into ensuring how organizations stay ahead in meeting compliance standards while optimizing operations.

Register for this webinar today to learn how a systems-based approach can streamline compliance and improve operational efficiency for internal auditing processes.

Speakers

Antiksha Joshi, Urmi Quality Management Consulting

Antiksha Joshi, Founder, Urmi Quality Management Consulting

Antiksha Joshi is an accomplished quality systems professional with over 20 years of experience in the pharmaceutical and life science industry. With a passion for improving organizational processes, Antiksha has played a pivotal role in implementing and enhancing QMS at various organizations.

Her expertise has been instrumental in leading successful regulatory audits and inspections, contributing to the overall success and reputation of the companies she has worked with. As the Founder and Leader of her consulting firm, Urmi Quality Management Consulting Pty Ltd, she is dedicated to supporting pharmaceutical and life science companies in achieving compliant, robust and user-friendly quality systems.

She also actively gives back to the community as a volunteer mentor for STEM students, inspiring and guiding the next generation of aspiring professionals in science, technology, engineering and mathematics.

Message Presenter
Cody Kestner, Ideagen

Cody Kestner, Senior Solutions Engineer, Ideagen

Cody Kestner is a Senior Solutions Engineer at Ideagen, where he advises customers in various industries, including life sciences, forensics and manufacturing, about how to best implement quality management solutions that suit their needs and goals.

Cody is passionate about helping organizations achieve quality excellence and continuous improvement through innovative technology and best practices.

Message Presenter

Who Should Attend?

This webinar will appeal to those working in the following fields or having the following job titles:

  • Quality Directors/Quality Managers
  • Lab Directors/Lab Managers
  • Compliance Officers
  • Operations Managers
  • Regulatory Affairs Specialists
  • Director/Head of Quality
  • Director/Head of Operations
  • Director/Head of Supply Chain
  • Director of Quality Assurance/Quality Control
  • Director of Regulatory Affairs
  • Head/Director of Clinical Operations

What You Will Learn

Attendees will learn about:

  • The six-systems approach utilized by regulatory inspectors
  • The tangible benefits of adopting a systems-based model in organizations
  • Practical tips and tools to implement a systems-based internal auditing program effectively

Xtalks Partner

Ideagen

We are the name trusted by organisations globally to deliver world-class, innovative software solutions in regulated or high-compliance industries such as life sciences, healthcare and manufacturing.

Whether you’re a large global corporation or a small to medium business, our solutions and services will help you solve complex quality, health and safety risk, audit and collaboration challenges.

You Must Login To Register for this Free Webinar

Already have an account? LOGIN HERE. If you don’t have an account you need to create a free account.

Create Account