Strategic Components for Tech. Transfer in Pharmaceutical industry

Speaker Biography:

Sami. M. A. Qassim, born on 5th. Dec. 1966, has B. Pharm. degree from Jordan University 1990 and Master in Pharmaceutical Technology from Jordan University of science and Technology 1997.
Sami over 34 years’ experience in pharmaceutical industry, mainly in Research and Development and Regulatory affairs. Lead the research and development and regulatory affairs in many MENAS pharmaceutical companies, out of which Tabuk Pharmaceuticals and Spimaco.
Sami worked as a consultant for many pharmaceutical companies, and he is now partner in a CRO company which provide development and analytical services for many pharmaceutical companies.
Sami participated in building the product portfolio, validating and launch of hundreds of products, managing tech. transfer activities to different company sites and build a strong team in the organizations with sustainable systems and performance.
Sami has many publications and patent in the field of formulation, analysis, stability and bioequivalence.

Course Outlines:

DAY 1

• Development Proposals.
• Scenarios.
• Pros And Cons for Each Proposal.
• Regulatory Requirement for Different Development Proposals..
• Scaling Up, Machine Parameters.
• Dossier Inspection for Tech Transfer Activities.
• Tech Transfer Real Case Studies  –  Solid Dosage Forms.
• Workshop For Tech Transfer Cases

DAY 2

• Analytical Method.
• Validation, Verification, Transfer.
• Common Variations Faced in The Tech Transfer Activity.
• Technology Transfer Project Management.
• Gap Analysis Between Transferring and Receiving Sites.
• Tech Transfer Real Case Studies  –  Liquid And Injectable Dosage Forms.
• Workshop For Tech Transfer Cases