Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers

This course will educate you about various key elements of sterility assurance and contamination control such as Cleanroom Regulations, Classification, Sources and types of particles, Design Requirements, Validation/Qualification, Operations, Environmental Monitoring Program requirements, Excursion investigations, DataTrending, Microbiological processes/methodology, Cleanroom cleaning/disinfection. The types of micro-organisms, typical mitigation steps in ensuring an effective contamination control through Personnel Training (Aseptic Practices, Cleanroom Behavior and Contamination Control Procedures),Gowning Controls, Personnel Training, Cleanroom Trafficking (Cleanroom Personnel Material, Product and Equipment Transfer Practices and Training (Entry and Exit Policy), Cleanroom Gowning, Contamination Control, Cleaning and Disinfection Program and the Basics of Sterilization Processes- 

The seminar will consist of two (2) Parts for a total of 6 Modules.

There are seven (7) key topics that will be discussed on Day 1 and Day 2 of the Seminar are as follows:

• Cleanroom Regulations, Classifications, Basic Background and Design Considerations
• Cleanroom Qualification, Cleaning Validation (IOQ/PQ), Routine Monitoring and Excursion Investigation
• Environmental Monitoring Program (Monitoring, Excursion Investigation and Trending of Data)
• Personnel Training (Aseptic Practices, Cleanroom Behavior and Contamination Control Procedures)
• Cleanroom Trafficking (Cleanroom Personnel Material, Product and Equipment Transfer Practices and Training (Entry and Exit Policy)
• Cleanroom Gowning, Contamination Control, Cleaning and Disinfection Program
• Basics of Sterilization Processes- Physical and Chemical Processes

Bonus:Compliance Expectations, FDA Form 483’s and Case Studies

Learning Objectives:

• Discuss Cleanroom Classification, Regulations and Guidelines
• Summarize how to Perform Cleanroom Design, Validation/Qualification, Operation, Environmental Monitoring Program and ensuring a state of control
• Describe Aseptic Practices, Personnel Health Practices, Gowning and Trafficking Patterns in a Cleanroom
• Establish and describe the Requirements of Cleanroom Cleaning/Disinfection and Contamination Control Practices
• Summarize various Sterilization Processes, Advantages and Disadvantages –both Physical and Chemical
• Describe the Sterilization Processes and Controls