Setting Up an Environmental Monitoring Program for Non-Sterile Manufacturing

This webinar will focus on the process of establishing an environmental monitoring program for non-sterile manufacturing facility and the need to design a system and routine that will satisfy the expectations of the global regulatory agencies. It will also address the different pharmacopeial regulations and current regulatory trends.

Why Should You Attend:

All non-sterile pharmaceutical products require some level of microbial control and bioburden testing. A satisfactory environmental monitoring program must ensure the best chances of consistent satisfactory microbial control of the environment.

• What exactly is needed to generate a sensible, practicable and reliable program for a non-sterile manufacturing process?
• What are the actions your company must consider in controlling a non-sterile environment?
• What and how to effectively set limits?
• Has your validation/qualification of the production areas demonstrated an accurate representation for creating a program that will accurately demonstrate control of the environment or possibly end up paralyzing the investigation backlog?
• Are there any actions that can be taken to prove there is no negative product impact due to environmental conditions?

This webinar will provide answers to all of these questions. It will review:

• What is significant as microbial contamination and what is historically acceptable bioburden.
• Setting up a baseline study along with a microbial profile.
• The sampling and test methods available, including species identification.
• Environmental monitoring, investigations and trending environmental data.

Learning Objectives:

Upon completion of this webinar, participants will be able to:

• Determine how to set a baseline microbial profile.
• Determine the historical trends and the action/alert limits for non-sterile production.
• Understand which sampling and test methods are more effective for use for each situation.
• Determine what a significant event is and what the product impact would be for the recovery of isolates of concern.

Areas Covered in the Webinar:

This webinar will review the various items that should be included in determining the validity of an environmental monitoring. The various elements of this presentation are summarized as follows:

• Defining what exactly is considered the acceptable historical trend in a non-sterile manufacturing environment
• Effective baseline monitoring
• Determining the microbial profile
• Focuses of protection from contamination
• Trending of data
• Requirements of the regulatory agencies
• Review of testing procedures
• Investigations

Who Will Benefit:

This webinar will provide valuable information to all companies that are in need of creating an environmental monitoring program for non-sterile manufacture of pharmaceuticals or the improvement, remediation of existing programs.

• QA/QC personnel
• Validation specialists
• Manufacturing personnel involved in validations
• Environmental monitoring specialists

Instructor Profile:

Steve Yeger, is Owner and President of Steven Yeger Consulting, a consulting firm based in the United States with 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.