Tuesday October 9, 2018
12:00 pm – 1:30 pm EST
Instructor: Barry A. Friedman, Ph.D.
USP/FDA Microbiological Non-Compliance Issues represent often 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>, <61>, <62>, <71>, <1072>, <1111>, and <1116>. Also, various Guidances for Industry are also included and often used within citations. One of the most notable 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 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 to explore how these issues may assist you in your facilities.
By attending you will learn:
- An Overview of “Microbiological Non-Conformance Issues”
- Various Code of Federal Register regulations, USP and FDA Guidance for Industry documents used by Regulators in Citations.
- Learn about the Legal Framework behind these Documents.
- Learn about Laboratory, the Classified Environment, Non-conformances of Personnel, and Cleaning and Disinfection Practices.
- Explore various Microbiological “Data Integrity” issues
- Participate in an Overview of a “Troubleshooting” Exercise.
- Experience what Companies have encountered with Warning Letters.
Those who should attend include:
- Microbiology
- Quality Control
- Quality Assurance
- Manufacturing
- Research and Development
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
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