Five Case Studies Using the E2500 Approach to Validate Equipment, … - Webinar CD/Transcript
Five Case Studies Using the E2500 Approach to Validate Equipment, Utilities and Facilities
The E2500 approach streamlines design qualification by focusing on design and verification of critical aspects of a manufacturing system that affect product quality and patient safety.
Implementation is not easy, but worthwhile. Once implemented E2500 can effectively reduce the testing, staffing, costs and time associated with the design-qualification phase of a system’s lifecycle.
Join Rich Yeaton and Christine Kielhorn, Ph.D. — both of Atlantic Technical and Validation Services — as they present case studies to illustrate key lessons they have learned from implementing the E2500 approach.
After this 90-minute session you’ll know:
- Why implement the E2500 standard
- Best practices for implementing the E2500 approach
- The benefits and limitations of E2500
- 5 valuable real-life case studies on:
- Solvent Mixing Skid and Chromatography Column
- Fermentation CMO First PAI
- Lack of Validation in a Biologics Facility
- Developing a “Wrapper” Protocol
- Developing a Microparticle Filter/Dryer FAT and IOQ
Order today and gain a clear understanding of FDA inspector expectations and how to meet those expectations for equipment, utilities and facilities validation.