Microbial Control, Monitoring and Validation of Water Systems for Pharmaceuticals and Biologics

Duration: 60 Minutes
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 Systems
Product ID: 501691
Objectives of the Presentation
  • 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.

Areas Covered
  • 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
Who will Benefit
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.

Topic Background
Pharmaceutical Water is the most important of all pharmaceutical utilities. It is used in many pharmaceutical formulations, as a cleaning agent and as a separately packaged product (diluent). Pharmaceutical facilities usually include systems for delivering pharmacopoeial Purified Water (PW) Water for Injection (WFI), and/or Highly Purified Water (HPW).
$375
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  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
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Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Gwendolyn Wise-Blackman is a successful scientist/manager with increasing accountability for scientific expertise and budget in the pharmaceutical industry, including managing multiple projects. She has working knowledge of FDA/ICH GLP and GMP guidelines and has proven experience with cell-based potency assays, Cell-based neutralization assays, PK and immunogenicity ELISA used to support bioprocess techniques for large molecule therapeutics. Ms. Wise-Blackman also holds Research & Development expertise in High Throughput Screening, 7-transmembrane receptor binding assays, cell-based assays, cell culture, and ELISA. Ms. Wise-Blackman is gifted with excellent presentation skills as evidenced by numerous scientific speaking engagements and working knowledge of PMP principles. She was an invited lecturer for IBC and IVT conferences, 1999-2008.
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