Lachman Consultants (Ireland) and NIBRT have partnered to offer a short course to help directly address Aseptic Manufacturing Compliance, including Annex 1 requirements, developing implementation strategies, maturity assessment, and planning for sustainable improvements.
Course Date: 4th October 2023
Location: On-site at NIBRT – Dublin, Ireland
Learn more about the course, including who should attend, learning outcomes, and registration here:
Aseptic Manufacture and Annex 1 with Lachman Consultants – National Institute for Bioprocessing Research (nibrt.ie)
Excerpt from the Course Descriptor on the NIBRT Website:
This one-day course, provided in collaboration with Lachman Consultants (Ireland), provides an insightful understanding of expectations and successful approaches to implementation of the revised Annex 1.
Learn from highly experienced practitioners, the training will provide exposure to methodology to assess compliance and maturity of the current state. The course leads the learners through basic principles to more advanced consideration and shares commonly used approaches. The course will cover key topics related to aseptic manufacture and compliance requirements.
The course will also share recent non-compliance trends and common challenges faced by aseptic manufacturing and provide the opportunity to discuss assessment or implementation challenges.
Key Topics Covered
- Environment classification and Standards (ISO and Grades A, B and C)
- Room Qualification (static and dynamic)
- Aseptic Process Simulation
- Key elements for Developing a Contamination Control Strategy
- Opportunity to discuss Industry challenges.
