Simplifying Global Compliance
Five Case Studies Using the E2500 Approach to Validate Equipment, Utilities and Facilities - Webinar CD/Transcript
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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.
- Engineering
- Project Management
- Commissioning and Qualification
- Quality Assurance
- Regulatory Affairs
- Manufacturing and Operations
Meet Your Presenters
Rich Yeaton, Owner, Atlantic Technical and Validation Services
Rich Yeaton has more than 25 years' experience working in FDA regulated industries. He was initially introduced to GMP operations on the Devices side as a development engineer in DuPont's medical products division, where he developed and improved new process equipment, and then was told to validate what he had designed. He is currently working with a GMP operating company to manage the renovation and subsequent validation of a pharmaceutical manufacturing facility for a phase III clinical product.
Christine Kielhorn, Ph.D., Director of Quality, Atlantic Technical and Validation Services
Christine Kielhorn has recent experience developing a process validation protocol for a drug delivery product that is surgically implanted into the eye to deliver API over an extended period of time. She also has recent experience providing scientific and quality assurance support for an API microencapsulation train as well as a production scale-up effort for an oligomer production process.