Sterile manufacturing and sterile filtration validation training course

16 July 2019

Lviv

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.

 

Agenda

09:00 – 10:50	Validation of sterile filtration: - analysis of risks when validating the filtration process; - study of the vitality of microorganisms, - bacterial retention
10:50 – 11.00	Coffee break
11.00 – 12.30	Validation of sterile filtration: - chemical Compatibility, - adsorption, - extractables and leachables,
12:30 – 13:30	Lunch break
13:30 – 15:50	Validation of sterilizing filtration: - testing of particles contamination, - testing of bacterial endotoxins contamination, - toxicity testing, - determination of criteria forintegrity testing
15:50 – 16:00	Coffee break
16:00 – 17:30	Sterile manufacturing best practices Answers to questions
17:30 – 18:00	Test

 

 

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