Experiences of managing a quality management system for a virtual pharmaceutical company
Instructor:
Simon Forster
Product ID: 700256
- Duration: 60 Min
An increasing number of smaller and start-up pharmaceutical companies are adopting the virtual model, whereby essentially all drug development activities are contracted out to CRO’s and other service providers, and the company itself is reduced to a small, largely office-based organization whose primary activity is to manage the activities of contractors. Nevertheless, to meet various regulatory obligations, in particular those of the sponsor of clinical trials, it is invariably still necessary for the virtual company to establish a quality management system. This webinar will discuss the advantages and disadvantages of the virtual model, with examples from personal experience. The material will also be useful to those companies which, while not adopting the full virtual model, contract out many or most of their development activities.
Areas Covered in the seminar:
- The virtual pharmaceutical company
- Virtual and semi-virtual models
- What kind of quality management system?
- Contracts, Technical Agreements and Quality Agreements
Who Will Benefit:
- Small pharma and biotech companies, particularly start-ups
- Clinical Trial Sponsors
- Monitors of outsourced nonclinical studies
- Purchasing and contract management specialists
Simon Forster has nearly 20 years experience in the UK biotech and biopharmaceutical industry, covering early stage R&D, analytical development, quality systems development, QC and QA management, GMP compliance and auditing. Currently Quality Management Consultant at Pharmaceutical Development Services Ltd, a consultancy company based in the UK, he has personal experience of various aspects of the virtual model and the management and monitoring of outsourced studies.
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