SPEAKER: Annual Bio Event | Tel Aviv, Israel

Novatek is proud to be participating as a speaker at the Annual Bio Event to be held June 15 in Tel Aviv at the David Intercontinental Hotel.  This conference will provide the most advanced information for understanding the operation and maintaining the quality of the sterile facility. Quality requirements in production and sterile pharmaceutical preparations – what is required, from the managers and quality people of preparation centers and production facilities, to understand about the clean rooms.

Novatek will be presenting on Risk-Based Contamination Control:

Presentation Title:

Annex 1 in The Age of Digitization: Reimagining Contamination Control Presented Virtually by Parsa Famili President & CEO, Novatek International

Overview:

• Optimized manufacturing and change control
• Using the Risk-Based Approach in Defining User Requirements
• The importance of clear roles and responsibilities
• Proper determination of Maximum Safe Carryover (MSC)
• Health-based exposure limits (HBELs)
• The trends and data analysis that support a total contamination control strategy (CCS)
• How to correlate or centralize trending of disinfectant qualification
• Effectiveness of cleaning
• Risks in Environmental Monitoring and Utility Monitoring
• Personnel gowning, and qualification
• Trending for investigational purposes across all contamination control elements to assist with root cause determination
• Doing Digital or Being Digital