Current Practices in Aseptic Processing

Online Live Training

Current Practices in Aseptic Processing

22nd – 23rd October 2020 | 10:00 AM | 4 Hours (Each Day)


Course Expert

Mr. Hitendrakumar Shah

A Quality-oriented professional with over 2 decades of experience in Quality Assurance, Quality Control, Quality Engineering, Quality auditor, pharmaceutical regulations, and regulatory audit compliance. The area of expertise is as per the requirement of USFDA, EUGMP, PICS, MHRA, TGA, TPD, ANVISA, WHO, and Schedule-M Guidelines.

Introduction:

Aseptic processing is a technology where the product and it’s components may be exposed to the processing environment and thus demands utmost care. The viable, non-viable and endotoxin contamination become grave concerns, if not handled properly in controlled environment. Best control is possible only by proper design of the facility, it’s good maintenance & utilities, timely validations and the aseptic practices followed by trained and skilled operating personnel. In order to maintain acceptable Sterility Assurance Level, regular training and proper supervision & monitoring is required.


Benefits of attendance:

  • How to Design Aseptic processing Facilities?
  • How to perform Quality Risk Assessment for an Aseptic facility including Isolation systems?
  • Rethinking on some Quality systems to enhance Compliance and Sterility Assurance Level.
  • How to Manage and Control Interventions and Contamination?
  • Rethinking on Advanced PAT Technology to add to Sterility Assurance Level, Productivity and Quality.
  • How to effectively engage the Sterilization processes to build-in assurance?
  • How to perform a Simplified yet assurance-filled Process Simulation?
  • How to be successful in regulatory inspections with consistency?

Who Should ATTEND?

  • Production
  • Packaging
  • Quality Assurance
  • Quality Control
  • Microbiology
  • Regulatory Engineering & Maintenance.

Register Now

Course Investment: INR 6500/-
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For Registration

Utsav Sahani – Head Registrations

[email protected] | +91 93214 97158