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