2014 - Validation Requirements for Sterile Products

Instructor: Kenneth Christie
Description:
The manufacture of sterile products and the risk they represent to the public is always on the fore front of inspectors during regulatory audits. As a result, the manufacture of sterile products require a high degree of control of incoming materials, the manufacturing process and the control of personnel to name a few.
A weakness in any of these items can jeopardize the sterility assurance of the final product. This webinar will highlight and summarize the following main components relating to current validation requirements for sterile products and include the following; review of the current regulations and guidance documents, the typical expectations when aseptic processing is involved, the expectations for protocols used to document the qualification of associated equipment, utilities and processes, and recently cited regulatory deficiencies. The intent of this webinar is to provide a template of things to assure are in place and practiced to help assure sterility and to be compliant.
Objectives of the Presentation:
Review the current regulatory requirements and guidance documents dealing with sterile products
Review the expectations for aseptically produced products
Discuss the six quality systems that are reviewed during regulatory inspections
Review common deficiencies cited with the manufacture of sterile drugs
Review the importance of personnel training and control of microbiological contamination
Who can Benefit:
QA/QC personnel
Manufacturing
Engineering
Validation
Regulatory
Management
Register Now:
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