COURSE DESCRIPTION

OVERVIEW

When the ASTM E2500 standard was released in 2007, it was billed as “The End of Validation as We Know It”. It created a significant stir, but, like most things identified as a magic bullet, didn’t deliver as advertised.

Validation is proving that your equipment, utility or process works to meet your (the company producing an API, Medical Device or Combination Product) needs. The E2500 approach can make the validation process more efficient and risk-based, but companies are still operating in the real world, where Murphy’s Law happens and human beings are an integral part of the process.  As a standard, not a regulation, it can be difficult to apply E2500 in alignment with FDA regulatory expectations.

In this webinar, we present an overview of E2500 advantages and limitations. We’ll work through several Case Studies to illustrate Key Lessons we’ve learned from implementing the E2500 approach over the past ten years, including tools and best practice recommendations.

We’ll also provide some thoughts and advice on dealing with the FDA and explaining to them how the E2500 approach works to result in compliant manufacturing systems.

LEARNING OBJECTIVES

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

• Describe the E2500 validation method
• Identify the regulatory expectations in regards to E2500
• Apply real world case study key lessons of the E2500 validation method to your company