This expert instruction on technology transfer of a pharmaceutical manufacturing process will highlight with real world examples hidden traps in technology transfer not covered under its requirements. This webinar will help attendees ensure the success of tech transfer under any circumstance regardless of fields, countries, cultures, and applications.
The webinar instructor, with over 20 years’ experience in more than 40 countries and in over 200 projects, will facilitate learning and understanding of the key principles behind cGMP-compliant technology transfer. He will simulate several real world scenarios for practical illustration and to facilitate participants’ understanding.
This webinar will help attendees:
Why Should You Attend:
Technology transfer brings together various people/departments across multiple professions, fields, cultures, and even systems. Consequently, the scope for conflicts is higher. Promoting the success rate to avoid traps, gaps, and risks requires experience and a keen understanding of the processes involved.The webinar instructor, with over 20 years’ experience in more than 40 countries and in over 200 projects, will facilitate learning and understanding of the key principles behind cGMP-compliant technology transfer. He will simulate several real world scenarios for practical illustration and to facilitate participants’ understanding.
This webinar will help attendees:
- Systematically conduct tech transfer
- Coordinate various departments with different backgrounds, expertise, regulations and cultures
- Foresee hidden traps
- Resolve conflicts of interests
- Remain target oriented with regard to time, budget and scope
- Assess and leave room for surprises or buffer in tech transfer
- Evaluate risks and return in technology investments
- Allocate resources needed for technology transfer
- Respond to potential damage control
- Understand how to apply for regulatory permits or approvals
- Arrange/conduct required training
Areas Covered in the Webinar:
- How to define technology performance specifications or tech transfer objectives
- Systematic approaches in technology transfer
- Requirements for both technology licensor/provider and licensee/receiver
- Hidden traps in technology transfer not covered in the requirements
- Conflicts from various departments, regulations, cultures, and fields/expertise and solutions
- Targets driven versus time, budget and scope
- Change control in tech transfer
- Return of technology investments
- Risks in hardware such as facilities/equipment versus software such as personnel of technology transfer
- Resource allocation for tech transfer
- Regulatory permits and approval
- Training and start-up
Who Will Benefit:
- Product, process and formulation development personnel
- Analytical development staff
- Personnel involved in the manufacturing process
- QA and QC staff
- Regulatory affairs personnel
- Project managers
- Engineers
- Scientists
- Technical staff
- Technology/technical managers
- Technology inventors and users
- Financial managers and investors
Course Provider
Mark Truei,
