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Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements - Webinar

  • ID: 4899974
  • Webinar
  • October 2018
  • Region: Global
  • 120 Minutes
  • Compliance Online
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Why Should You Attend:

This course will offer a broad review of:

Different filtration media with the construction characteristics and properties of each detailed
A typical pharmaceutical sterile filtration system with its individual components
Engineering schematics
Microbiology and particle retention mechanisms
Integrity testing methods and media qualification
Procedures for the sterilization of the filter (SIP, autoclave, etc.)
The proper validation of sterile filtration is important to ensure that the filter will reproducibly remove undesirable components (bioburden) while allowing passage of desirable components (drug product). The operating parameters of time, pressure and temperature will be fully discussed along with the filter's potential effect on the product (compatibility, leachables, fibers, endotoxin, etc.). Microbial retention challenge testing is one of the validation requirements and the instructor will offer insights on the same.

At the end of the course, the instructor will present a compilation of all FDA/EU GMP regulatory guidances concerning sterile filtration. In keeping with these guidances and requirements, the responsibilities of the filter manufacturer vs. the filter user will be thoroughly analyzed.

Areas Covered in the Webinar:

Sterile Filtration - Importance of Quality
Sterility Assurance of Sterile Filtration
Sterile Filtration System Design
Discussion of Different Filtration Media Properties and Retention Mechanisms
Methods for Sterilization of Filters
Validation of Sterile Filter Systems
Microbial Retention Challenge Testing
Integrity Testing
Product Compatibility Testing
Extractable/Leachable Testing
Regulatory Requirements
Note: Product cover images may vary from those shown
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Roger Cowan is the founder and owner of R Cowan Consulting Services LLC, a consulting company specializing primarily in the area of pharmaceutical contract manufacturing. He has 35 years' experience in pharmaceutical quality assurance and manufacturing. In his career, Mr Cowan has held various manager / director positions in quality assurance, QC laboratory, technical services validation, manufacturing, and clinical supply manufacturing and distribution. He has taught courses in microbiology at Seneca College (pharmaceutical technology program) in Toronto, Canada.

His areas of expertise include: aseptic pharmaceutical manufacture, GMP facility audits, technical transfer, microbiology, environmental monitoring/contamination control, product sterilization, process development, process validation, clinical supply manufacturing, labeling and distribution, US / International regulatory requirements, regulatory submissions, and quality assurance/control.
Note: Product cover images may vary from those shown
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