Validation of Microbiological Test Methods

 

 

Instructor: Barry A. Friedman, Ph.D. (more about the instructor)

Validation of Microbiological Test Methods represents a basic requirement within the pharmaceutical/biotech industries to assure that microbiological methods are reproducible and consistent, that methods developed for one product type will perform or be modified to perform for another product type, to improve process reliability and demonstrate product safety and reliability. Validations are also developed to determine both Alert and Action Levels as well as acceptable limits and specifications for microbiological test methods. Finally, regulatory pressures also expect that methodologies are validated as required and not merely qualified or verified.

This Executive Conference Corp. (ECC) webinar will discuss the elements involved in validating a microbiological test method as well as demonstrate what is involved with both “qualitative” and “quantitative” microbiological tests. It will elaborate on several of the most pertinent references to include PDA Technical Report No. 33 and USP<1223> Validation of Alternative Microbiological Methods.

Finally, the webinar will discuss the development of a microbiological validation, the plan design, equipment requirements, equipment DQ/IQ/OQ/PQ, vendor selection, preparation of test samples and demonstrating method appropriateness.

This webinar, as presented by ECC, represents an excellent opportunity for team participation and understanding of this important area. Please plan to join me on Thursday, May 3, 2018.

By participating, you will learn:

• What constitutes a microbiological validation
• The elements involved in validating a microbiological test method
• How PDA TR No. 33 and USP<1223> may assist in developing and executing a validation
• Development of an validation
• How a validation differs from a qualification or verification
• PAI problems that arise if a laboratory has not validated a method

Fee:
$385 for one person
$700 2-5 people
$999 6-10 people

 

 

Questions? support@eccwebinars.com

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