FDAnews Announces — Five Case Studies Using the E2500 Approach to Validate Equipment, Utilities and Facilities Webinar, March 15, 2017

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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. Join Rich Yeaton and Christine Kielhorn, Ph.D. — both of Atlantic Technical and Validation Services — on March 15 when they’ll present case studies to illustrate key lessons they have learned from implementing the E2500 approach.

Five Case Studies Using the E2500 Approach to
Validate Equipment, Utilities and Facilities
**An FDAnews Webinar**
March 15, 2017 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/5casestudies            

What have manufacturers learned from using E2500?

When carefully implemented, the E2500 approach can effectively reduce the testing, staffing, costs and time associated with the design-qualification phase of a system’s lifecycle. It makes the startup and validation process more efficient, it documents startup efforts and it identifies problems early.

There is still a lot to be learned in how to implement it correctly and know its limitations.

Join Rich Yeaton and Christine Kielhorn, Ph.D.,both of Atlantic Technical and Validation Services, on March 15 when they’ll present five case studies to illustrate key lessons they have learned from implementing the E2500 approach.

After this 90-minute webinar attendees will 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:

o    Solvent Mixing Skid and Chromatography Column
o    Fermentation CMO First PAI
o    Lack of Validation in a Biologics Facility
o    Developing a “Wrapper” Protocol
o    Developing a Microparticle Filter/Dryer FAT and IOQ

Register today and gain a clear understanding of FDA inspector expectations and how to meet those expectations for equipment, utilities and facilities validation.

Meet the 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.

Who Will Benefit:

  • Engineering
  • Project Management
  • Commissioning and Qualification
  • Quality Assurance
  • Regulatory Affairs
  • Manufacturing and Operations

Webinar Details:
Five Case Studies Using the E2500 Approach to
Validate Equipment, Utilities and Facilities
**An FDAnews Webinar**
March 15, 2017 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/5casestudies            

Tuition:
$287 per site

Easy Ways to Register:
Online: http://www.fdanews.com/5casestudies                                        
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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