For products that claim a desired Sterility Assurance Level (SAL), proof of a defined SAL (specification) is achieved through the product’s sterilization and sterility assurance controls. Compliance Observations cited each year by the FDA on Form 483s that relates to Sterilization and Sterility Assurance processes shows that there are deficiencies associated with these key processes that are critical to a product’s sterility including inappropriately qualified and trained personnel required as key staff to implement a fully compliant sterilization process.
This can potentially lead to Product Failures (Sterility Failures), product Non-conformances, Product Recalls, FDA’s Warning Letters, Consent Decrees and discontinuance of commercial operations which may negatively impacts a company’s profitability. FDA regulated industries that produce products with a defined SAL are obligated to have adequately trained and knowledgeable staff or Subject Matter Experts (SMEs) within sterilization and sterility assurance to provide applicable regulatory guidance with the impacted systems.
This accredited training introduces both new and existing employees to the requirements of aseptic processing preparation and filtration of solutions. The webinar describes the factors, steps, principles, applications and working mechanisms of filtration sterilization while comparing and contrasting the different types of filtration processes and types of filters used for filtration of solutions during sterile drug manufacturing process.
The attendees will also gain an understanding on the process steps required to validate the filters used for sterile filtration of products as defined by regulations using Brevundimonas diminuta. This webinar will provide attendees detailed regulatory agencies expectations on the use and validation of different types of filters and their respective roles in today’s manufacturing activities.
Upon completion of this course, you will be able to:
This training is part of the 10-course series required for the Cobblestone Sterilization Professional Certification Program. Attend this as a step in the certification process or as a stand-alone course for personal career advancement and training.
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This online training will benefit professionals working in the Pharmaceutical, Biotechnology, Drug, Biologics, Medical Device, Compounding Pharmacies and In-vitro Diagnostics Product Manufacturing industries.
It will be especially valuable for personnel and management within the following areas:
When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.
Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.
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