A Quality Systems Approach to Risk-Based Technology Transfer - Reducing Regulatory Problems and Improving Performance

cGMP trainingLive Web Training Course
Thursday, June 17, 2010
(1:20 p.m. – 3:30 p.m. EST)Course Details
(12:20 p.m. – 2:30 p.m. CST)
(10:20 a.m. – 12:30 p.m. PST)Pricing
Instructor: Frank S. Kohn, PhD

frank_kohn2Introduction: (Session was originally scheduled for June 8, 2010)

A risk analysis approach to technology transfer in the pharmaceutical industry can lead to a significant improvement in not only cost reduction, but can also minimize regulatory delays and potentials failures. Being first to market is of significant benefit to both consumers and the company sponsoring the drug. This live and interactive BenAstrum web training course will help provide the needed tools companies require to gain maximum benefit during the transfer of drugs from location to location, as well as from R&D to production.

In the current regulatory climate for pharmaceutical licensing, informational exchange across department lines is a component of the competitive advantages gained by companies employing a risk analysis approach to technology transfer. Effective and efficient transfer and start-up of new products can significantly reduce cost and save companies millions of dollars. This course will draw upon current research and review industry “best practice” to optimize the overall process.

Discussion Points:

  • Better understanding of the scientific basis and process fundamentals to technology transfer
  • Improve informational exchange and integration across departments
  • Reduce regulatory problems
  • Improve performance in meeting timelines
  • Review risk analysis tools and how to apply them

Learning Benefits:

  • Learn how to be first to market using risk analysis approach
  • Gain insights in how to avoid common pitfalls in the transfer of products
  • Learn how to partner with QA groups during technology transfer
  • Develop a better understanding in the use of risk analysis as a strategic advantage for your company

Who Can Benefit:

  • QA personnel
  • QC personnel
  • Supervisors
  • Managers
  • R&D
  • Technology transfer personnel
  • Manufacturing staff
  • Validation staff
  • Project managers

Please click here for the course agenda