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

Event Details

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

Time: February 3, 2021 at 10am to February 4, 2021 at 5pm
Location: online
Street: Compliance Online, 2479 E. Bayshore Road
City/Town: Palo Alto
Website or Map: https://www.complianceonline.…
Phone: 8887172436
Event Type: seminae
Organized By: ComplianceOnline
Latest Activity: Jan 21

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Event Description

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

Who will Benefit:

This training will benefit those involved in the manufacturing, processing, testing and release of sterile and non-sterile products. It will provide the attendee an understanding of the basic concept of microbiology, microbiological and contamination control practices, cleanroom design, routine testing, qualification/validation and use of cleanrooms as well as the typical sterilization processes (Physical and Chemical) within various industries such as the Pharmaceutical, Biotechnology, Drug, Biologics, Medical Device and In-vitro Diagnostics Product Manufacturing Industries, especially personnel and management in:

  • Quality Assurance
  • Quality Control
  • Manufacturing
  • Validation
  • Supplier Quality Assurance
  • Regulatory Affairs
  • Shipping and Receiving
  • Facility and Maintenance
  • Engineering
  • Materials Management
  • Analysts
  • Analytical Chemists
  • All levels of management
  • Microbiologists

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