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Date: 6th May, 2010
Location: On-Line, North America
Summary:Pharmaceutical - Web Seminar
Click here to Register for this Seminar
Validation of microbiological test methods is gaining interest in today’s environment, with the issuance of PDA Technical Report No. 33, 'Evaluation, Validation and Implementation of New Microbiological Testing Methods', USP <1223> 'Validation of Alternative Microbiological Methods', and 'AOAC INTERNATIONAL Qualitative and Quantitative Microbiology Guidelines for Methods Validation', as well as the continuous evolution of rapid microbiological methods.
With the FDA most willing to participate in more rapid microbiological in-process and final product releases and the opportunity to obtain results in hours, rather than days, a litany of companies are developing their versions of rapid microbiological methods. The questions for each of us are what is most applicable to both our in-house and regulatory requirements and are they cost effective. To perform these analyses, we need to examine the DQ/IQ/OQ/PQ of these various instruments as well as microbiological method validation.
The objective of this live and interactive BenAstrum web training course is to explore the validation of microbiological test methods and the efforts required to satisfactorily meet their validation requirements.
Discussion Points: - Characteristics of traditional and contemporary methods
- New technology for microbiological testing
- Initial considerations required to meet the microbiological plan design
- Establishing analytical procedures based on process/product requirements
- Developing acceptance limits for products, components and processes
- Elements of a microbiological validation
- Review of validation criteria and recommendations for satisfying each as part of a microbiological validation
- Validation plan design
Validation of Microbiological Test Methods Live Web Training Course - Webinar
