Essentials of USP Microbiological Testing

Course Description

Course establishes a practical understanding of microbiological practices in the pharmaceutical industry and provides an overview of the USP General Chapters which address microbiological testing. Next, selection of elective topics are picked for discussion based on the needs of the students.

Who Should Participate

This course is intended for those who directly work in the microbiology lab, or interact with those who do.

Format

Traditional classroom

Duration

1 full day

Fee

$695.00

Registration

Learning Objectives

I. Core Topics:
  • The Nature of Microbiology
  • Metabolism and Environmental Requirements
  • Taxonomy & Identification
  • Basic Lab Practices
  • Variability of Microbiological Data
  • Overview of Microbiological Testing General Chapters in USP 30:
<51> Antimicrobial Effectiveness Testing
<55> Biological Indicators
<61> Microbial Limit Tests
<62> Microbial Examination of Non–Sterile Products: Tests for Specified Microorganisms
<71> Sterility Tests
<81> Antibiotics – Microbial Assays
<85> Bacterial Endotoxins Test

II. Elective Topics:
  • Sterility Testing (1 hr)
  • Sterilization & Sterilization Assurance (1 hr)
  • Microbial Enumeration & Absence of Microbial Contamination (2 hrs)
  • Microbial Identification (1 hr)
  • Antimicrobial Efficacy Testing (1 hr)
  • Validation of Microbial Recovery – General Chapter <1227> (1 hr)
  • Validation of Alternative Microbiological Methods – General Chapter <1223> (1 hr)