4-Hour Virtual Seminar on Aseptic Processing and Validation

This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.

Cleanroom classifications and the techniques for proper cleaning and disinfection are presented; along with a high-level overview of microbiology in regards to cleanroom environmental monitoring and the associated impact to product and patient health and safety. This course will also review the guidance provided in USP <1116> to ensure compliance with regulatory expectations are met.

This is a course for people who need to understand the technical fundamentals of aseptic processing or who are responsible for aseptic operations in a lab, pilot or commercial setting. This aseptic training course is ideally suited to management teams, industrial microbiologists, scientists and engineers either with technical or managerial responsibilities in the biotechnology and pharmaceutical industries. FDB3085

Areas Covered in the Session:

  • Explain the difference between Aseptic and Bulk processing
  • Understand facility and personnel requirements necessary to maintain microbial control
  • Explain basic principles of microbiology and microorganism recovery in relation to cleanroom environmental monitoring (EM) and impact to product
  • Understand the gowning requirements associated with different cleanroom classifications
  • Explain basic principles of aseptic processing, including:
    • Cleanliness classifications
    • Process differences between aseptically produced and terminally sterilized product
    • Relation of manufacturing and handling procedures to sources of product contamination
    • The differences between cleaning, disinfection and sanitization
    • Proper cleaning / disinfectant technique
    • Elements of a robust environmental program and why EM is important
    • The role of isolator technology
  • The purpose of media fills, and elements critical to their success
  • Identify behaviors that are or are not appropriate when working in controlled areas, and why
  • Identify ways that they can impact/improve site-specific EM and aseptic behavior issues

Kelly Thomas

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

Lecture 1: Basic Micro Review
– The role of environmental monitoring
– Types & sources of microorganisms
– The impact of microorganisms on product and patient health and safety

Lecture 2: Review Aseptic Processing Basics
– Cleanliness classifications
– Process differences between aseptically produced and terminally sterilized product
– Relation of manufacturing and handling procedures to sources of product contamination
– The differences between and the purposes of cleaning, disinfection and sanitization
– Proper cleaning techniques
– The role of isolator technology

Lecture 3: Review Clean Area Behaviors
– Personnel gowning requirements
– Good clean area behaviors/practices
– Practices to avoid – and why
– Review site-specific EM/aseptic behavior observations/risks

Lecture 4: Aseptic Validation
– The purpose of media fills, and elements critical to their success

  • Quality Assurance Department Management and Staff
  • Quality Control Department Management and Staff
  • Operations Department Management and Staff
  • Records Managers
  • Production Management and Staff
  • Engineering Department Management and Staff
  • Validation Management and Staff
  • Facilities / Maintenance Management and Staff

membership

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
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