Important requirements when validating sterilizing grade filters - ComplianceOnline Biotechnology Training 2010

This sterilizing grade filter validation training will provide valuable assistance in validating sterilizing grade liquid filters within the pharmaceutical and biotech processes.

Why Should You Attend:
Sterilizing grade membrane filters are used in many applications within the biopharmaceutical industry, most critically though as a point-of-use filter before the filling process. These filters require appropriate process validation to verify the filter performs as specified, for example retaining microbial contaminants and/or avoiding release of leachables or particulates.

In this webinar multiple validation process steps will be described and discussed in regard to methodology and criticality. These validation processes include, viability, product bacteria challenge testing, extractable/leachables testing, unspecific adsorption, particle release, chemical compatibility and product wet integrity testing.

Areas Covered in the Seminar:

• What is filter qualification, what is filter validation.
• Regulatory requiremnents validating sterilzing grade filters.
• Various validation requirements and processes.
• Practical experiences with filter validation.
• Documents required.

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that need to validate their sterilizing grade liquid filters within the pharmaceutical and biotech processes. The employees who will benefit include:

• End-users of sterilizing grade filters
• Validation manager or specialists
• Regulatory manager or support
• Quality assurance manager
• Regulatory agency personnel
• Consultants