Who Should Attend
This course is intended for individuals from:
• Product Development
• Regulatory Affairs
• Quality Assurance
• Analytical Development
• Process Development
• Quality Control
• Project Management and Planning
• Package Engineering
• Manufacturing
Participants will benefit by gaining a better understanding of the complexities of technology transfer in the pharmaceutical industry.
Description
This course will provide a basic understanding of the technology transfer of analytical methods, quality control standards, packaging components/operations and various pharmaceutical dosage forms from R&D to manufacturing. It is designed to provide an overall understanding of the issues affecting the transfer within and outside a company.
Topics will include transfer of technology to/from international sites as well as to/from third parties/CROs. Regulatory requirements and recommended approaches will be discussed. Speakers will use practical examples to highlight issues critical to successful technology transfer. Best practices from several pharmaceutical companies and contract manufacturers will be presented and contrasted.