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      Sterile Filtration of Pharmaceutical Products in Middletown

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      November 14, 2019

      Thursday   1:00 PM - 2:00 PM

      Compliance Key,364 E Main Street, Suite 1009
      Middletown, Delaware 19709

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      Sterile Filtration of Pharmaceutical Products

      Topic : Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

      Register :

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      Sterile filtration is one of the most critical steps in sterile pharmaceutical manufacture. This is because the filtration process provides the assurance of sterility in the finished drug product.
      Therefore, the design, validation and ongoing monitoring of a sterile filtration system are essential for assuring the quality and safety of the pharmaceutical product.
      Proper understanding and testing of the sterile filtration system according to international regulatory standards is essential for both the validation and ongoing monitoring of the system.

      Areas Covered in the Session:

      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

      Speaker Profile :

      Roger Cowan is the Keynote Spaker at ComplianceKey. He 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, Roger has held various manager / director positions in Quality Assurance, QC Laboratory, Technical Services Validation, Manufacturing, and Clinical Supply manufacturing and distribution. Roger has taught courses in microbiology at Seneca College (Pharmaceutical Technology Program) in Toronto, Canada.

      Contact Info :

      Compliance Key

      Email :

      Phone : +1 717-208-8666

      Categories: Conferences & Tradeshows | Health & Wellness

      Event details may change at any time, always check with the event organizer when planning to attend this event or purchase tickets.

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