PharmaTraining Services, Copenhagen, Denmark
16 & 17 October 2007
Day 1
8.45 Registration and coffee
9.15 Introductions
Tablet formulation development
Understanding the relationship between
manufacturing formula and process
How are processes and formulas arrived at?
How are they controlled?
10.45 Coffee
11.15 Key manufacturing processes -
purpose, equipment and control (1)
Blending and lubrication
Dry Granulation—Roller compaction and
slugging
Wet Granulation
12.30 Lunch
14.00 Blending for direct compressionWe follow the development of a formulation from hand filled capsules to production tablet manufacture, reviewing blending options and actual results.
FDA requirements for blend uniformity assessment 15.00 Blending scale-up and segregation
15.30 Tea
16.00 Key manufacturing processes -
purpose, equipment and control (1)
Drying
Sieving
Tablet compression
Film coating
17.00 End of Day 1
Day 2
9.00 Process Control Case study - Granulation-end point
control
How can we can we control granulation
processes?
End point selection
How do granule properties relate to key
processing parameters?
10.30 Coffee
11.00 Scale up of high speed mixer granulation
Segregation
Capping
How to address these problems?
Including mixing, granulation and
compression problems
12.00 Documentation of Process Development
12.30 Lunch
14.00 Quality control in tablet manufacture
Assuring tablet quality during and after
manufacture
14.30 Principles of validation
Regulatory guidance on validation—FDA and EU
What is the purpose of Process Validation
and where does it fit in the quality system,
and production transfer
PreApproval Inspections (PAIs) and process
qualification
15.30 Tea
16.00 Developing process validation protocols
Planning and developing protocols based
on process development data
16.30 Summary and Q&A
17.00 End of Course
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