Process Validation Basics Program Overview
Program Description
Documentation is the core of any Process Validation program. There are regulations requiring documented evidence that a specific process will repeatedly produce a product that meets specifications. In this program, all the components of process validation will be defined and fully described with examples applicable to blood banking. You will learn to differentiate between verification and validation; and know when each applies. The components of a good validation plan are explained in easy to understand language along with questions to help guide decision-making. The single most important element of process validation is to understand the requirements of good validation.
Learning Objectives
- Define Validation and the terms used in the validation process
- Describe the components of process validation
- Differentiate between validation and verification
- Describe Validation Documentation Requirements
Level of Instruction
- Basic
P.A.C.E. Statement
Blood Systems, Inc. is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program
In 1977, P.A.C.E.® was established by the American Society of Clinical Laboratory Science (ASCLS) to stimulate and serve as the quality assurance mechanism for continuing education programs offered to clinical laboratory professionals. ASCLS strongly supports continuing education opportunities to increase and enhance professional knowledge and ongoing proficiency. P.A.C.E.® ensures that the continuing education programs offered to clinical laboratory professionals maintain high standards of quality and professional acceptability.
Contact hours
- Completion of this program will provide 1.0 contact hours of continuing education credit.
Technical Requirements and Assistance
To view the program material, you need a computer with a supported web browser and a dial-up or better internet connection. The supported operating systems and web browsers are:
Operating Systems
- Windows 2000, XP, Vista
- MacOS X 10.4 or later
- Linux 2.6 with KDE or Gnome
Web Browsers
- Internet Explorer 6 or later
- Firefox 2 or later
- Safari 3 or later
- Opera 9 or later
Technical Support
- Email: Contact Us
- Telephone: 1-888-376-1260
Content Questions
-
Linda Stefaniak B.S. (ASCP) SBB CQA (ASQ) CQM/OE
lstefaniak@bloodystems.org
602-370-8016 cell phone
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P.A.C.E. is a registered trademark of American Society for Clinical Laboratory Science