Microbial Control, Monitoring and Validation of Water Systems for Pharmaceuticals and Biologics
Duration : 60 Minutes
Gwendolyn Wise-Blackman,
Gwen Wise-Blackman has 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly Magellan Laboratories and Cardinal Health), Covance, and Salix Pharmaceuticals. Her focus has been in High-Throughput Screening, Cell-Based Assay Method De Read more
This webinar will discuss the FDA requirements for design, validation and monitoring of pharmaceutical water systems. There are many different types of pharmaceutical waters and each must be fit for its intended use. Pharma water must be controlled microbially and for other impurities. Pharma water systems must be designed, validated and monitored to ensure that the water produced meets specifications around the clock. Learn common pitfalls with water system design and use and how to avoid them. Get your pharma water questions answered in this webinar.
Course Objectives:
• Pharmaceutical water requirements
• Pharmaceutical water system design
• Pharmaceutical water system validation
• Pharmaceutical water system monitoring, deviations, CAPAs
• Regulations and guidance
• Microbial control
Why Should You Attend:
Attend this webinar to learn in depth about pharmaceutical water, how to design systems for appropriate microbial control; to learn the minimum requirements for validation of pharmaceutical water systems. Also learn the different types of pharmaceutical water and their requirements and fitness for intended use and more.
Course Outline:
• Pharmaceutical water types
• Water requirements per product type
• Water system requirements
• Applicable regulations and guidances for pharmaceutical water
• Water system design and unit operations
• System validation and points to consider
• Validation acceptance criteria and validation periods
• Common pitfalls and how to avoid them
• Control of biofilms
• Sampling programs
• Microbial control and monitoring
• Use of process analytical technology (PAT) and rapid methods
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Validation Managers and Personnel
• Engineers involved in water System design and Installation
• Utility operators and their Managers involved in maintaining and sanitizing water systems
• QA Managers and Regulatory Affairs Personnel involved in defending water system operations and quality data to FDA and EMEA Inspectors and outside Auditors
• QA Managers and personnel involved in investigations of excursions and preparing CAPAs
• QC Laboratory Managers and Personnel involved in Sampling, Testing, and Trending Chem and micro data from water systems
• Consultants and Troubleshooters
Professionals in the pharmaceutical and biologics industries, where high purity water systems are used, should attend this program. Those in QA, compliance lab personnel, R&D, and engineering would also benefit from this session.
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
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