Sterile Pharmaceutical Manufacturing Facility Training Course

24 – 25 May 2018

Kiev

Trainer:
Denys Ostrovnoy

 

 

Course Objectives
  • To understand the mechanisms of contamination transfer from source to product and the protective measures in place to prevent product contamination
  • To have the opportunity to work with risk management techniques
  • To understand the key control measures and they impact the sterility assurance of the product
  • To introduce new thinking for qualification & validation based on risk assessment
  • To follow the EU GMP and cGMP regulations and guidelines for aseptic processing and to engage in discussions regarding industry changes and best practices

 

Target group
Anyone who wants to know more about GMP, such as quality control, quality assurance, and operations staff who perform GMP activities.

 

 Workshop program:

24.05.2018

10:00 – 11:15

 Terms and definitions.
Requirements for the production of sterile drugs.
How to choose the sterilization method

11:30 – 13:00

- General principles as applied to the manufacture of medicinal products
- Pharmaceutical quality system
- GMP requirements to aseptic processing and terminal sterilization
- Formulation of sterile pharmaceuticals

13:00 – 14:00

Lunch break

14:00 –15:30

Area classification requirements
Environmental Monitoring - Compliant and Reasonable
Justification and monitoring of critical process parameters

15:45 –17:30

Restricted Access Barrier Systems & Isolator

25.05.2018

10:00 – 13:00

Validation of the sterilizing filtration:
  •  regulatory requirements for sterilization
  •  risk analysis during validation of the filtration process
  •  study of the viability of microorganisms
  •  bacterial retention
  •  chemical compatibility
      •  adsorption
      •  extractables and leachables
  •  product-wetted integrity testing
  •  toxicity testing

13:00 – 14:00

Lunch break

14:00 – 15:30

Intervention risk analysis
Qualification and validation as a tool to reduce the risks of drug non-sterility
Validation of Aseptic Processes (MFT)

15.40 – 16.45

 Practical workshops

16.45 - 17:30

Test

 

 

 







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