Aseptic Process Overview 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.

Areas Covered in the Session :

At the completion of this course, attendees will be able to:

• Explain the difference between Aseptic and Bulk processing
• Understand facility and personnel requirements necessary to maintain microbial control
• 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
  • Elements of a robust environmental program and why EM is important
  • The role of isolator technology
• Process Validation Requirements: How to Perform a Successful Media Fill
• Process Validation Requirements: Sterile Filtration Validation

Who Should Attend:

• Quality Assurance Departments
• Quality Control Departments
• Facilities Departments
• Engineering Departments
• Operations Departments
• Manufacturing Teams
• Quality Engineers

Course Director: 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.