USP/FDA Microbiological Non-Compliance Issues in a Biopharmaceutical/Pharmaceutical Environment

USP/FDA Microbiological Non-Compliance Issues often represent observed problems that occur with both non-sterile and sterile products in controlled and classified environments as well as within the microbiological laboratory. Various regulators will cite firms for these non-compliance issues under a variety of different sections of the Code of Federal Register (CFR) to include 21 CFR 211.113(a) and (b), 211.84(d)(6), 211.165(b), and 211.192. Non-compliance issues are also cited as per United States Pharmacopeia to include USP<51>, <60>, <61>, <62>, <71>, <1072>, <1111>, <1113> and <1116>. Also, various Guidances for Industry are also cited and often used within Observations. One of the most notable Guidances is the September 2004 FDA Guidance for Industry on Aseptic Processing.

Some of the most frequent non-compliance issues include those within the laboratory, the classified environment, failure to meet USP, non-conformances of personnel, and cleaning and disinfection practices. In today’s environment, often they include “Data Integrity”. This live, interactive Executive Conference Corp. webinar will also review various investigations – using various FDA Warning Letters to explore issues with bacteria and fungi. A chronology will be included that reviews microbiological non-compliance.

The Objective of this live, interactive Executive Conference Corp. training webinar is to explore the “Best Practices for Managing Microbial Non-Compliances” and examine solutions to common microbiological problems. Please plan to bring a team to this Webinar (barryafriedmanphdllc.com) to explore how these issues and their solutions may assist you in your facilities.