Full Day Virtual Seminar: Understanding and Effectively Controlling Biofilm in Pharmaceutical Water Systems

This 6-hr training will focus on important microbial issues with pharmaceutical water systems and provide proven solutions for microbial control. Attendees will learn effective sanitation and validation approaches to successfully control biofilm in water systems.

Why Should You Attend:

This interactive one-day course provides a thorough understanding of what makes water systems have microbial problems with proven solutions for microbial control.  It also details how to validate that control by determining the operations and processes that logically must be evaluated in pharmaceutical water and steam systems during the validation exercise in a manner that will please FDA.

Duration:

6 hours of instruction, one hour lunch, and short breaks as they fit into the schedule.

Agenda (times Eastern)

• 10:00am (7am Pacific)-11:30 Module 1: Biofilm: Understanding What Makes Water Systems Have Microbial Problems (1:30)
• 11:30-1:00pm Module 2: Successful Sanitization and Microbial Control Approaches for Pharmaceutical Water Systems (1:30)
• 1:00-2:00 Lunch hour
• 2:00-3:30 Module 3: Purposeful Water and Steam System Validation – Not Just A Regulatory Requirement (1:30)
• 3:30-3:45 Afternoon break
• 3:45-5:15 Module 4: Reducing Microbial Excursions and Improving Investigation Outcomes (1:30)
• 5:15-5:30 Q&A

Who Will Benefit:

• Engineers responsible for water system design and fabrication
• Maintenance personnel responsible for water system maintenance and sanitization
• Microbiological personnel involved in collecting and testing water system samples
• Validation personnel involved in writing and executing water system validation protocols
• Quality Assurance professionals involved in deviation investigations and oversight/approval of all other water system activities as well as those involved in defending water system issues to regulatory investigators who may or may not be water experts themselves
• Regulatory Affairs professionals involved in describing water and water systems in regulatory filings and also those involved with regulatory inspections
• Managers and supervisors of all these disciplines who need to understand what makes water systems unique design, control, monitoring, validation, and investigative challenges.