Introduction to Method Validation (EMU 400)

Participants will learn the history of method validation, understand conceptual differences to topics such as quality control/quality assurance, and method validation/method verification. In-depth discussions will focus on the elements that appropriately validate an analytical method with respect to method type and provide participants with a template for the method validation process.

 

Prerequisites

Participants should:
- Be proficient in spreadsheet use
- Have an understanding the requirements for method validation and verification of ISO/IEC 17025:2017

EQUIPMENT NEEDED:

The participant will need to bring a laptop computer with Microsoft Excel or similar spreadsheet installed.

 

Learning Outcomes


After successful completion of the course, participants will be able to:

1.    Discuss the history of method validation from USP, FDA and GxP perspectives
2.    Describe the concepts and differences between quality control and quality assurance
3.    Define terms such as accuracy, precision, specificity, ruggedness and detection limits, etc.
4.    Given data, determine repeatability, reproducibility and ruggedness
5.    Identify and describe the different Method Validations by type
6.    From memory, outline the required contents for documenting and validating a method
7.    Using a validation template, choose a method type and perform a mock validation

CEUs Awarded

0.7 CEUs Awarded*

 

*American Association for Laboratory Accreditation (A2LA) is accredited by the International Association for Continuing Education and Training (IACET) and is authorized to issue the IACET CEU.

Contact

Training

March 26, 2019
Hyatt Regency
1800 Presidents Street
Reston, VA 20190
8:00 AM – 4:30 PM

April 11, 2019
MicroTek - LA
222 Noth Pacific Coast Highway, Suite 1240
Los Angeles, CA 90245
8:00 AM – 4:30 PM

May 23, 2019
NCEE Labs
4740 Discovery Drive
Lincoln, NE 68521
8:00 AM – 4:30 PM

September 26, 2019
MicroTek - Denver
999 18th Street, Suite 300, South Tower
Denver , CO 80202
8:00 AM – 4:30 PM

Additional Location Info:

Hotel information: https://www.mclabs.com/room-rentals/microtek-denver/

October 11, 2019
A2LA
5202 Presidents Ct.
Frederick, MD 21703
8:00 AM – 4:30 PM

October 30, 2019
MicroTek - Portland
15495 SW Sequoia Parkway, Suite 100,
Portland , OR 97224
8:00 AM – 4:30 PM

Additional Location Info:

Hotel information: https://www.mclabs.com/node/5336/

December 12, 2019
MicroTek - San Francisco
655 Montgomery Street, Suite 400,
San Fran, CA 94111
8:00 AM – 4:30 PM

Additional Location Info:

Hotel information: https://www.mclabs.com/room-rentals/microtek-san-francisco/

PLEASE NOTE: Registration for public training courses will close 7 days prior to the start date.
A2LA can offer on-site training at your facility. For additional information about this option, please submit a quote request here.