ComplianceOnline

Experiences of managing a quality management system for a virtual pharmaceutical company

Instructor: Simon Forster
Product ID: 700256
  • Duration: 60 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This quality management system webinar will discuss the advantages and disadvantages of the virtual models and useful to those companies which, while not adopting the full virtual model, contract out many or most of their development activities.

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

Instructor Profile:

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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Product Reviews Write review

As a consultant to "virtual" pharmaceutical companies, I was looking for a more comprehensive discussion of the particular ways in which a virtual company can implement a QMS. In other words, how to do it; not that I need to do it. Less on what a virtual company is and more on details of which elements and the scope of the elements of the QMS for a "Sponsor" company is needed.
- Anonymous

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