Webinar Details:

This webinar will cover the Annex I risk-based approach to materials transfer into Cleanrooms, RABS, isolators, Glove Boxes and BSC’s. New industry guidance from PDA and IEST will be covered. There will be a focus on how to control hard to kill fungal spores such as Aspergillus and Penicillium as well as bacterial spores and viruses. Recent case studies from the past few months in cell and gene therapy and compounding pharmacies will be discussed in relation to materials transfer. Published data will also be mentioned to convey effective methods in control bioburden into the APA (Aseptic Processing Area). This presentation will be a holistic approach to controlling bioburdens from entering BSC Hoods, open RABS, and cleanroom operations. There will be an emphasis on using a risk based approach for materials transfer from warehouses to Aseptic Processing Areas.

Key Takeaways:

• Learn how to access risk assessments for materials transfer.
• Discuss the weakest points in materials transfer from the warehouse into the aseptic core.
• Define the best process for materials transfer of delicate items
• Sterilization options for materials transfer
• Disinfectant qualification methods for materials transfer items

Who Should Attend the Webinar:

• Validation Managers
• Quality Control Managers
• Quality Assurance Managers
• Lean Managers
• Operations Managers
• Cleanroom Managers
• Regulatory Affairs Managers
• Production Managers
• Quality Systems Managers
• Sustainability Managers
• CCS Managers

Fee:
$385 for one person
$700 2-5 people
$999 6-10 people

Register for ECC-749