Overview:
This would describe how to build and operate a compliant supplier qualification process . Things to look for and do’s and don'ts.
Why you should Attend:
Many manufacturers get into trouble by not properly qualifying their suppliers with the result that they receive FDA citations. This causes delays or problems when they are manufacturing clinical candidates or commercially license products. This can be a big source of disruption and lead to problems when it comes to regulatory submissions connected with those products/candidates.
Areas Covered in the Session:
- How to select candidate to qualify
- The aspects of the suppliers business to consider developing a profile of
- How to audit them
- How to assess their capabilities
- What approval and disqualification issues to consider
Who Will Benefit:
- Manufacturing Purchase Groups
- Operations Staff and Quality Assurance Staff