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HomeRegulatory & ComplianceImplementing the ASTM E2500 Validation Method: 10 Years of Key Learnings

Implementing the ASTM E2500 Validation Method: 10 Years of Key Learnings

Teachers
Kelly Thomas
Category:
Manufacturing & Good Manufacturing Practices (GMP) Training/ Medical Device Training/ On-Demand Courses/ Quality/ Regulatory & Compliance/
Clear

— OR —

Duration: 90 minutes
On-Demand
Includes handouts
  • Description
  • Who Should Attend
  • What To Expect

Description

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

Who Should Attend

WHO SHOULD ATTEND

This course will be of benefit to anyone working in a GMP regulated environment on global or domestic scale that is responsible for validation activities, such as reviewing, executing or approving validation protocols and summary reports.  This includes personnel in:

  • Quality
  • Manufacturing
  • Engineering

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 and use Option 3 (9am – 5pm EST, M-F) for assistance.

About Instructors

Kelly Thomas
Kelly Thomas | cGMP QA/QC Expert

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Clear

— OR —

Duration: 90 minutes
On-Demand
Includes handouts

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