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DESCRIPTION
Validation of aseptic processes is essential to ensuring the successful end result for manufacturers-safe, effective finished product. However, the process starts long before that. Active ingredients and sterile bulk material must achieve the appropriate level of sterility assurance. This training will provide an in-depth overview of the requirements for cGMP compliant aseptic process validation. This includes a detailed overview and analysis of mandates and guidance from several entities, including the US Food and Drug Administration (FDA), the Pharmaceutical Inspection Co-operation Scheme (PICs), and the European Union (EU). This interactive session will also highlight industry best practices, and discuss common errors and deficiencies.
MATERI Training Online – Antiseptic Process Validations = TOP-TIPS for Compliance and SuccessAL
1. Interpret the Requirements of the FDA, EU and PICs Guides to Aseptic Processing
2. Identify All the Elements of a Complete Aseptic Validation:
3. Recognize the Requirements Associated with Media Fills including :
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Topik Training | : Online Training – Antiseptic Process Validations = TOP-TIPS for Compliance and Success |
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