The ‘United States Pharmacopeia India’ (USP) has launched a course on ‘Rapid Microbiological Methods’. The course will be held on March 3 and 4, 2014 in Mumbai and Ahmedabad. Considered to be the leader in pharmacopeial education, the course is aimed at those who are directly at microbiological lab and to those who interact with microbiology technicians. The course will help in understanding the advantages and disadvantages of classical microbiological methods and their validation in the pharmaceutical industry.
Some of the key learning objectives are:
Learning about alternative microbiological methods.
Be able to discern between review referee and release tests, and between verification and validation.
Understand the application of the compendial and regulatory guidelines:-
a. USP–NF General Chapter ‹1223› Validation of Alternative Microbiological Methods
b. EP 5.1.6 Alternative Methods for Control of Microbiological Quality
Understand the concept of “equivalent or better”.
Review the most common modern/rapid microbiological methods:-
a. Growth-based technologies
b. Artifact-based technologies
c. Viability-based technologies
d. Nucleic acid–based technologies
“USP courses are developed by ‘USP Subject Matter Experts,’ scientists who help support the setting of USP standards followed in more than 140 countries and presented by ‘USP Approved Instructors,’ scientists with practical first hand knowledge of specific subject areas and proven professional presentation skills suited for the pharma industry. Dr Radhakrishna Tirumalai, Principal Scientific Liaison, General Chapters, United States Pharmacopeia, Rockville, US, will be the faculty for ‘Rapid Microbiological Methods’ course in Mumbai and Ahmedabad.
EP New Bureau– Mumbai
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