Outsourcing analytical and pharmaceutical development
Instructor:
Michael Gamlen
Product ID: 700231
Training Level: Basic
- Duration: 60 Min
The selection and management of contractors for pharmaceutical and analytical work is difficult and complicated. In this webinar I will outline my tested process for:
- Developing an outsourcing strategy
- Defining the work to be outsourced
- Contractor identification and evaluation
- Preparation of Work Specification
- Contractor selection
- Monitoring of contractor performance
- What to do when things go wrong
Areas Covered in the Seminar:
- Being a good contractor – meeting customer requirements
- Being a good client - developing a clear outsourcing strategy Defining the work to be outsourced – what is the work to be outsource?
- Identifying and evaluating contractors – what should clients look for in contractor
- Requests for Proposal – defining what is needed to be done in way that comparable quotes can be obtained
- Contractor selection – what contractors do to make the difference
- Monitoring contractor performance – performance standards. What should the client expect?
- What to do when things go wrong. What goes wrong most often, and how to ascertain the true cause of a problem
Who Will Benefit:
People involved in the outsourcing of analytical and pharmaceutical either as outsourcers or as service providers, including:
- Product development specialists and technologists
- Analytical chemists
- Quality control staff
- Quality and analytical managers
- Quality system managers and administrators
- Formulation scientists
- Regulatory affairs personnel working in CMC areas
Michael Gamlen has over 25 years of teaching and product development expertise. He has been responsible for outsourcing of numerous projects and programmes in the Chemistry, Manufacturing and Controls areas including pharmaceutical and analytical areas. He has extensive experience of contractor troubleshooting, and setting up Quality Systems to ensure that outsourcing systems meet their goals. He is the founder of Pharmaceutical Development Services Ltd, a UK based company specialising in outsourcing management, Quality System development and the provision of regulatory services.
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