The United States Pharmacopeia (USP) contains a number of chapters relating to microbiology within its General and General Information Chapters. These Chapters present information that relate to both non-sterile and aseptic processing. Several of these chapters have been recently updated and all have been updated since 2009. Each of these Chapters has relevance to each other and provides a significant knowledge base of microbiological requirements. Several of these have also been harmonized and permit one to not only follow the USP, but simultaneously meet the requirements of both the European and Japanese Pharmacopeia.

Delivered by Barry A. Friedman, Ph.D., a Senior Consultant in the Biotechnology, Regulatory Compliance, and Aseptic Processing arena, this intensive annual live training program on the topic of USP Microbiological General and Information Chapters will consist of 7 live training sessions of 2-hour presentation time followed by 30 minutes of live Q&A each as follows:

• Tuesday, April 14, 2020 - Part 1: USP <61>/<62> Microbiological Enumeration & Examination of Non-Sterile Products – Understanding the Current Standards for the New USP and Harmonized EP Microorganisms
• Thursday, April 16, 2020 - Part 2: USP <1111> Microbiological Examination of Non-Sterile Products; Controlling Microbial Contamination in Pharmaceutical/Biotech Non-Sterile & Sterile Manufacturing and the New Regulatory Attitude
• Tuesday, May 5, 2020 - Part 3: USP <1115> Bioburden Control of Non-Sterile Drug Substances and Products– A New USP General Information Chapter
• Thursday, May 7, 2020 -Part 4: USP <1072> Disinfectants and Antiseptics - Use and Application of Sanitizers, Disinfectants and Sterilants
• Tuesday, June 2, 2020 - Part 5: USP <51> Antimicrobial Effectiveness Testing – A New 2016 Revised Chapter
• Thursday, June 4, 2020 - Part 6: USP <1116> Microbiological Control and Monitoring of Aseptic Processing Environments and Its Comparison & Contrast to FDA’s Guidance; Aseptic Processing (2004) and Annex 1 (2009)
• Tuesday, July 7, 2020 - Part 7: USP <71> Sterility Tests; Method, Limitations, Sampling Quantities and Volumes to Conform with United States Pharmacopeia Pharmacopoeia