Course Description:

The various regulatory agencies have expectations that oral solid dosage pharmaceutical manufacturers will demonstrate control over the manufacturing environment; however, there are no clear guidelines on how to establish such a program. The FDA’s findings of deficiencies concerning cleaning validation and disinfectant efficacy in particular indicate the agencies expect definitive evidence that the cleaning and sanitation schedules of a facility will satisfactorily control the environment. Examples of FDA form 483 findings for disinfectant efficacy indicate deficiencies in many of these studies.

The cost of non-compliance is therefore more than that of compliance. Are you in compliance with the FDA regulations for cleaning validation in your non-sterile manufacturing facility?

This highly interactive two day seminar on regulations for cleaning validation will explain the different global agencies expectations of disinfectant efficacy and qualification along with the development of a sound environmental monitoring baseline program in order to develop and implement bulletproof solutions in microbial control that are accepted, effective, and efficient. Through case study analysis it will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system. Additionally, case studies will explore how your management practices of your environmental monitoring program can help or hurt your legal liability and the legal issues that arise from nonconformance with regulators and auditors.

Learning Objectives:

Upon completing this course on regulations for cleaning validations participants will:

  • Understand what the global expectations are for non-sterile production environmental monitoring.
  • Be able to utilize a risk based approach for developing an effective and scientifically justified monitoring system.
  • Evaluate effectiveness, suitability and adaptability of cleaning, sanitation and disinfection.
  • Understand the difference between the acceptable historical trends and significant deviations from those trends that constitute undesirable contamination.
  • Be able to investigate true root causes of problems and to evaluate and prioritize solutions.
  • Learn problem solving methods to help them assess which are best for their situation.
  • Be able to develop successful implementation plans.
  • Learn how to perform risk assessments effectively.

Who will Benefit:

This course is designed for people tasked with developing, maintaining and/or improving environmental monitoring programs for non-sterile manufacturing facilities. This includes individuals that have Quality Management Systems responsibilities for making general improvements in their organization’s performance specifically related to microbial control of the manufacturing environment. Following personnel will benefit from the course:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production supervisors
  • Manufacturing engineers
  • Production engineers
  • Design engineers
  • Process owners
  • Quality engineers
  • Quality auditors
  • Document control specialists

Course Outline:

Day One (8:30 AM – 4:00 PM) Day Two (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

  • Introduction to the microbial aspects of cleaning validation
    • Defining the what and how of contamination
    • How bioburden enters into the product
  • The meaning of adulteration
  • Regulatory requirements and expectations
    • Recent updates
    • Expected changes
    • Global harmonization and expectations
  • Prevention of “contamination”
    • Protection from contamination
    • Controlling the undesirable bioburden
  • Cleaning, sanitation and disinfection
    • Efficacy studies
    • Qualification in-situ and initial environmental monitoring studies
  • Designing the program
    • Fundamental considerations
    • Policies and procedures
    • Risk mmnagement as a critical tool

  • Defining the two basic focuses of non-sterile environmental monitoring
    • Controlling the number of microbes
    • Controlling the undesirable/objectionable species
  • Initial establishment of historical trends
  • Establishment of a baseline microbial profile
  • Initial monitoring
    • Setting the limits
    • Trending
  • Risk analysis as a tool
    • Setting sample sites
    • Setting sample frequency
  • Sample and test methods
  • Investigations
  • Review of FDA Warning Letters
  • Case Study Exercise from current FDA Warning Letters
  • Theoretical case exercises
  • Questions

Meet Your Instructor

Steve Yeger,
President- Technical Consultant, Steven C. Yeger Consulting Inc.

Steve Yeger is owner and President of Steven Yeger Consulting, a consulting firm based in the United States that has serviced pharmaceutical clients worldwide. Prior to starting his Consulting career, Steve worked for Wallace Laboratories, Inc. as the group leader of medical diagnostics-infectious diseases , Bristol-Myers Squibb bacteriology, managed the Microbiology department at PACO pharmaceutical ( a CMO) and managed quality operations for antibiotic manufacturers and clinical supplies. Steve holds a Bachelor of Science degree in Microbiology from the Ohio State University and has over thirty years of experience in the medical diagnostics, medical devices and pharmaceutical industries.

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