Aseptic Processing, Validation and Challenges - From Regulator`s Perspective

Aseptic Processing, Validation and Challenges - From Regulator`s Perspective is a course dedicated to the technical fundamentals of aseptic processing.

Aseptic Processing, Validation and Challenges - From Regulator`s Perspective covers topics such as:

  • Facility and personnel requirements necessary to maintain microbial control
  • The difference between Aseptic and Bulk processing
  • The gowning requirements associated with different cleanroom classifications
  • Basic principles of microbiology and microorganism recovery in relation to cleanroom environmental monitoring (EM) and impact to product
  • The role of isolator technology
  • Basic principles of aseptic processing, including: Elements of a robust environmental program and why EM is important
  • Behaviors that are or are not appropriate when working in controlled areas, and why
  • The purpose of media fills, and elements critical to their success
  • Ways that they can impact/improve site-specific EM and aseptic behavior issues

Aseptic Processing, Validation and Challenges - From Regulator`s Perspective brings together:

  • Quality Control Management and Staff
  • Quality Assurance Management and Staff
  • Regulatory Affairs Management and Staff
  • Research and Development Management and Staff
  • Engineering Management and Staff
  • Manufacturing Management and Staff
  • Production Management and Staff
  • Operations Management and Staff
  • Process Owners
  • Validation Management and Staff
  • Quality Auditors
  • Documentation Management and Staff

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