Home » Online Training – Antiseptic Process Validations = TOP-TIPS for Compliance and Success
Online Training – Antiseptic Process Validations = TOP-TIPS for Compliance and Success
January 4, 2022
Jadwal Pelatihan Online Training – Antiseptic Process Validations = TOP-TIPS for Compliance and Success
| Tanggal | Tempat | Kota | | Belum ada jadwal terbaru |
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:
- Container Closure Integrity
- Container Closure Sterilization
- Filter Validation
- Equipment Cleaning/Disinfecting
- Equipment Maintenance and Testing
- Sterility Testing
- Personnel Training
- Environmental Monitoring
3. Recognize the Requirements Associated with Media Fills including :
- Define the importance of media fills/process simulations to sterility assurance
- The methods for simulating an aseptic process for the various types of products, i.e. liquid, semi-liquid and solid dosage forms
- State the validation requirements and acceptance criteria for aseptic media fills
- Identify “worst case” conditions and critical interventions
