This program will focus on both in-process and product release quality control, including Bioburden, Endotoxin and Sterility Testing. The training will provide an overview of relevant methods in each area; however, basic technical laboratory skills are assumed as a prerequisite for participation.
Understand the current requirements of pharmacopeias and be familiar with good testing procedures from method development/validation through to routine test result interpretation
Take preventive actions to avoid false positive or false negative test results
Develop and optimize testing procedures
Understand and identify root causes of common issues
Who Should Attend:
The course is designed for quality control microbiology professionals, quality assurance or regulatory affairs personnel who have responsibility for the performance of Bioburden, Endotoxin & Sterility Testing or for data review, pharmacists performing sterile compounding.
Introduction to Quality Control
Quality of the specimen
Standard operating procedures (SOPs)
Proficiency testing / External quality assessment
NOT INTERESTED IN THIS COURSE?
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