Scaling up from mg to Kgs – Making your First GMP Batch
6th – 7th October 2016, Clearwater, USA
“the course was very informative and it allowed me to see the big picture from discovery stage to pilot plant”
Genentech
Course Outline:
- Introduction
- Making the first 100g non-GMP Batch
- Non-GMP vs GMP preparation
- Physical version and form
- Process safety and raw materials supply
- Scaling into fixed vessels
- Technology transfer
- Genotoxic impurities
- Case studies and Review
Who should attend:
- Project managers
- Project leaders
- Bench chemists
- New starters
- MedChem Support teams
This course aims to provide attendees with a good understanding of the issues involved taking development candidates to the first in human trials.
Click here to Download the Course Brochure
Presented by Dr John Knight, JKonsult Ltd
Managing Director at JKONSULT Ltd
Click here to Download the Course Brochure
“Brilliant Course, learn lots of tips and tricks”
Vertex
“First incursion into Chemical Development has been very, very educational. John’s way of explaining the material has been wonderful.”
Almirall
“Very clear and interesting sessions with a lot of relevant examples and not only theory.”
Oribase Pharma
Oribase Pharma
LINK
LITERATURE FROM INTERNET ON HIS TOPIC
//////////Scaling up, mg to Kgs, Making, First GMP Batch, SCIENTIFIC UPDATE, JOHN KNIGHT, Clearwater, USA
Filed under: COMPANIES, GENERICS Tagged: Clearwater, First GMP Batch, JOHN KNIGHT, Making, mg to Kgs, Scaling up, SCIENTIFIC UPDATE, USA