Preventing contamination of injectable drugs is critical to patient safety. Close scrutiny from the FDA and other global agencies keeps industry focused on effectively managing this risk. ISPE has long been recognized for high quality education events on the latest technology related to Aseptic Processing. This conference brings together both industry and regulatory representatives to highlight significant issues related to Barrier Isolation – RABS and Aseptic Processing Technologies and Disposables.
At the conclusion of this conference, participants will be able to:
- Understand and implement the latest technologies related to aseptic processing
- Clarify directly with regulators current GMP expectations to share with company leadership
- Apply lessons learned from user companies who can provide insights and benchmarks
- Impact company strategies and approaches to aseptic processing issues and challenges
Regulators to provide current perspectives on Aseptic challenges and answer your questions during interactive panel discussion!
Questions and issues emerging from conference presentations and discussions will be presented for the regulatory panel to address during the concluding session. You won’t want to leave early from this conference!
Industry Roundtable: Keys to Addressing Quality System Issues in Aseptic Manufacturing Which May Lead to Shortages
Panel discussion with industry leaders focusing on quality reasons for drug shortages in aseptic manufacturing. The panel will review root causes, company initiatives for mitigation and avoidance, as well as partnership with Regulatory Bodies. Facilitated by ISPE’s Drug Shortages Initiative team.
- Members of the ISPE Drug Shortages Initiative Team
- FDA, Invited