Technology Transfer of a Pharmaceutical Manufacturing Process
Instructor:
Mark Truei
Product ID: 703682
- Duration: 90 Min
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
Mark Truei, Ph.D., has extensive hands-on experience in technology transfers in over 40 countries in the USA/North America, Europe, Asia, Mid/South America, and Africa, in various industries with more than 200 global clients. He has a wide knowledge on academic training in manufacturing process technologies across various fields. He holds a successful track record in all operational functions/positions in manufacturing, R&D, QC/QA, facility engineering/construction, clinical trials/permits, marketing/sales, and regional/national/business-unit head.
Mr. Truei was China/Asia head of Arena Pharmaceuticals, a US public biopharm company, senior plant/pilot plant/QC/QA manager at Telios Pharmaceuticals, another US public biopharm company, and R&D group leader at Lederle Labs, a leading US pharma company. In US service/consulting industry, he was director of Asia business development of Bio-Kinetics, the co-founder and technology director of CDI Engineering Group, the founder/president of Hatch USA, and project manager at Raytheon.
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
