Wednesday, October 22, 2008
9:00 AM - 5:00 PM (Lunch 12:00 PM - 2:00 PM)
| Session 201 - Practical Process Validation Solutions to Industry Processes |
Instructor: Brian Callahan, EEC & Associates
This session will discuss:
- Evolution of Validation
- Installation Qualification
- Operational Qualification
- Performance Qualification
- Process Validation
- Statistical Tools and Techniques
|
Abstract
Learn the necessary elements needed to complete a process validation successfully while taking into account the objectives of the business! This interactive course will consist of two breakout activities that will demonstrate the effectiveness of process validation. Industry best practices will also be demonstrated and offered as compliance approaches to most industry validation scenarios. During the seminar, participants will interact with the instructor to ensure that every element between validation master planning and statistical analysis is used in an effective and easy-to-understand format. Course attendees will receive current reference documents, templates, and a binder to ensure an effective learning experience that can be applied immediately.
About the Instructor
Brian Callahan, President, EEC & Associates
Brian Callahan is an independent consultant in the medical device regulatory field. He was formerly director of education for Quintiles Consulting and provided compliance training to clients worldwide. He has designed and delivered training modules that include IQ, OQ, PQ, process validation, preparing for an FDA investigation, validation master planning, SPC, executive management responsibility, reagent manufacturing, and test methods. Brian has more than 12 years of industry experience, nine within medical devices, IVDs, and drugs. He has validated facilities domestically and internationally to ensure cGMP compliance for the production of Class I, II, and III medical devices.
