Aseptic Processing, Validation and Challenges - From Regulator`s Perspective 2019

Aseptic Processing, Validation and Challenges - From Regulator`s Perspective 2019 is a course dedicated to the technical fundamentals of aseptic processing.

Topics

• 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

Who should Attend

• 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