Technology Transfer of a Pharmaceutical Manufacturing Process

Instructor: Mark Truei
Product ID: 703682
  • Duration: 90 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

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CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

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.

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

Instructor Profile:

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.

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