This biotech training will provide valuable assistance to all regulated companies (Pharma, OTC etc) that manufacture non-sterile products.
The Microbial Limits Tests of the three major pharmacopeia are in the final processes of harmonization and are scheduled to be fully implemented in 2009. These provide guidance on compendial testing of bioburdens and specified organisms and guidance on setting specifications. This presentation will cover the tests in board overview and discuss the differences between compendial tests for specified organisms and the manufacturer's obligation to minimize the presence of objectionable organisms.
Harmonization Status.
Differences in new “Microbial Enumeration” test < 61>.
Differences in new “Absence of Specified” test < 62>.
Differences in new < 1111>.
The Microbial Limits Tests of the three major pharmacopeia are in the final processes of harmonization and are scheduled to be fully implemented in 2009. These provide guidance on compendial testing of bioburdens and specified organisms and guidance on setting specifications. This presentation will cover the tests in board overview and discuss the differences between compendial tests for specified organisms and the manufacturer's obligation to minimize the presence of objectionable organisms.
Areas Covered in the Seminar:
What is involved in the new MLT?Harmonization Status.
Differences in new “Microbial Enumeration” test < 61>.
Differences in new “Absence of Specified” test < 62>.
Differences in new < 1111>.
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies (Pharma, OTC etc) that manufacture non-sterile products. The employees who will benefit include:- End-users responsible for finished product testing
- QA managers and personnel
- Consultants
- Quality system auditors
Course Provider
Scott Sutton,
