Objectionable Microorganisms in Medicinal Products - Aseptic Environment

Course Description:

According to 21 CFR 211. 165, there should be appropriate laboratory testing of each batch of drug product required to be free of objectionable microorganisms. Recently there have been several warning letters and recalls related to objectionable microorganisms. This webinar will focus on the FDA regulations on aseptic processing and definition of Objectionable Microorganism. This training will explain FDA’s current stance on the topic of objectionable microorganism and will help the attendees to prevent trends and set up an applicable risk assessment strategy for objectionable microorganism.

Course Objective:

FDA regulated manufacturers of medicinal products are required to establish quality systems to ensure that their product meet up all requirements and specifications. GMPs require product manufacturer to perform risk assessment techniques in order to minimize the objectionable microorganism in the medicinal products. This course will help the attendees to understand the role objectionable microorganisms play in maintaining the safety and quality of a medicinal product. The FDA unfortunately is not clear on defining what constitutes “objectionable microorganisms,” and often it’s left up to the organizations themselves to make that determination. This session will review FDA regulations and guidance on aseptic processing and provide definitions of “objectionable microorganisms.” This webinar is designed to help organizations focus not so much on an almost impossible task of preventing the presence of objectionable microorganisms in their aseptic environment, but, on the task of preventing trends and setting up an applicable risk assessment strategy.

Areas covered under the webinar:

• Review of recall data
• FDA regulations
• FDA guidance on Aseptic Processing
• ICH guidelines
• Definitions of “objectionable microorganisms”
• Risk assessment of the presence of microorganisms in the aseptic environment and its impact on product

Who will benefit:

This webinar is beneficial for the regulatory personnel in:

• Manufacturing
• Quality system auditors
• QA directors and managers
• Microbiology analysts and technicians
• Consultants
• Regulatory and Compliance Management