This course provides detailed parameters on validation and verification of microbiological tests, recovery from pharmacopeial articles, and validation criteria for qualitative and quantitative tests. It also covers validation of alternative microbiological methods. The chapters covered in this course are:
– <1223> Validation of Microbiological Methods
– <1227> Validation of Microbial Recovery from Pharmacopeial Articles

Subject area:
Drug Products & APIs

Objectives (If applicable):
– Apply understanding of validation and verification of compendial and alternative microbiological methods.
– Implement validation and verification of compendial and alternative microbiological methods.

Target Audience (If applicable):
– QA/QC staff
– Regulatory affairs managers
– Scientists
– Microbiologists
– Investigators
– Other professionals who work or interact in a pharmaceutical microbiology laboratory environment.