Desember 2020HSEOnline Training

Online Training – Antiseptic Process Validations = TOP-TIPS for Compliance and Success

Jadwal Pelatihan Online Training – Antiseptic Process Validations = TOP-TIPS for Compliance and Success

TanggalTempatKota
22 - 23 Desember 2020--

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
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