Comprehensive Seminar on Everything You'd Like to Know about Pharmaceutical Water Systems, But were Afraid to Ask

• Annex 1 and its Comparison to Compendial mandates: What does it all imply to the industry
• Comparison of Hot water, Chemical, and Ozone Sanitization for Pharmaceutical Processes
• Continuous/Electro Deionization (CEDI)
• Instrumentation, Measurements, Testing of Source, Pretreatment, and Pharmaceutical Waters
• Lessons Learned from and In-depth FDA Investigation
• Microbial Issues and its Mitigation in Pharmaceutical Waters
• Myths, Misconceptions, and Realities: The Legacy of Obsolete SOPs and Specifications in Modern Pharmaceutical Water Systems
• OPEX and CAPEX The Actual Cost Pharmaceutical Water Systems
• PAT (Process Analytical Technology): An FDA and Industry Effort
• Possible ideas, approaches, and directions for future production, process, cGMP compliance, and critical utilities
• Production of WFI Water Without Distillation - New Changes in the European Pharmacopeia
• Rapid Microbial Monitoring: Regulatory and Application Strategies for Pharmaceutical Water Systems
• Source Water Microbial and TOC Destruction in Pretreatment Pharmaceutical Water Systems
• Sustainability - The Reclaim, Recycle, Reuse and Reduction of Water in Biopharmaceutical Production
• The Use of Statistical Process Control (SPC) and Exponentially Weighted Process Statistics (EWPS) for PAT in Pharmaceutical Water Systems
• Understanding and Troubleshooting Pharmaceutical Water Systems
• Validation of a Pharmaceutical Water System for the 21st Century
• Water for Injection (WFI): A Changing Paradigm of Production Methods – USP Perspective
• Water for Pharmaceutical Use / Water Purification Engineering

Learning Objectives:

You will learn and understand the following:

• Pharmaceutical Water systems
• The operations of a pharmaceutical water system
• The basic chemistry involved in water purification
• The options of choosing properly defined equipment for individual purification steps
• The issues of microbial monitoring and sampling
• The value of different sanitization methods used in pharmaceutical water systems
• The difference of gram-negative and gram-positive bacteria and their influence in biofilm development
• The configuration of CEDI, EDI, and Ion Exchange is removing ions from the water
• The usage of microfiltration (MF), ultrafiltration (UF), and nanofiltration (NF)
• All modules used in pharmaceutical water production from source water to finished product water supplied to production.
• The different regulatory, pharmacopeial, and international regulatory issues associated with pharmaceutical water.
• What lessons can be learned from a regulatory audit or investigation.
• The usage of Statistical Process Control and Exponentially Weighted Process Statistics to monitor and control your water system long before it hits an action or alert limit.
• The usage and production of non-distilled WFI.

Who will benefit:

Pharmaceutical, Over-the-Counter, Beauty, Nutraceutical, Biotechnology, and medical device industry professionals in engineering, critical utilities, technical competencies, maintenance, quality control, quality assurance, engineering management, global responsible production personnel.