Microbial Control, Monitoring And Validation Of Water Systems For Pharmaceuticals And Biologics

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.

• Pharmaceutical water requirements
• Pharmaceutical water system design
• Pharmaceutical water system validation
• Pharmaceutical water system monitoring, deviations, CAPAs
• Regulations and guidance
• Microbial control

• 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

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.

• 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.

Gwen Wise-Blackman, Ph.D., 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), and Salix Pharmaceuticals. She is currently Principal Consultant at Gwen Wise-Blackman Consulting. Her career focus has been in High-Throughput Screening, Cell-Based Assay Method Development and Validation, and Quality Assurance. Gwen has a Bachelor of Science degree in biology from M.I.T and a PhD in Pharmacology from UVa. She is a member of ASQ and AAPS