DRAFT AGENDA
| 08.30 – 09.00 | Registration with tea/coffee |
| 09.00 – 09.45 | Introduction to sterile manufacturing- What does sterile mean?
- Why do we need sterile products?
- Sterile vs aseptic – are they the same?
|
| 09.45 – 10.30 | Introduction to microbiology- What is microbiology?
- The bacteria, moulds and yeasts, virology, parasites and TSEs
- Controlling and understanding microbial growth
|
| 10.30 – 11.00 | Morning break with tea/coffee |
| 11.00 – 11.45 | Introduction to cleanrooms- What is a cleanroom
- Cleanroom grades and controls
- Design and equipment
- Cleanrooms as a contamination control system
- Cleanroom behaviours
|
| 11.45 – 12.30 | Methods of sterilisation- Moist and dry heat
- Filtration
- Irradiation and e-beam
- Chemical
|
| 12.30 – 13.30 | Lunch |
| 13.30 – 14.15 | Process manufacturing- Common product dose forms
- How to manufacture these dose forms
- Isolators RABS and open filling
- Blow fill seal, freeze drying
- Process simulations, media fills and broth trials
|
| 14.15 – 15.00 | Sterility assurance- What is sterility assurance?
- Risk based manufacturing
- Determination of sterility
|
| 15.00 – 15.30 | Afternoon break with tea/coffee |
| 15.00 – 15.45 | Sterile manufacturing and the regulations and compliance to GMP- Why is there a need for regulations?
- Who regulates the pharmaceutical industry?
- Are you inspection ready?
|
| 15.45 – 16.00 | Closing remarks |
To register your interest please click here maxine@pharmig.org.uk
