Project Management: Pharmaceutical Technology Transfer

Provided by NUS Academy of GxP Excellence


Course introduction

Introduction


Objective

To benefit project managers and technical professionals in understanding the advantage of technology transfers, the adverse consequences that may be associated with improper planning and the approach to successful technology transfers.

Description

There is an increasing number of technology transfers in pharmaceutical industry today due to its impending benefits such as creating a competitive edge against its competitors. However, improper planning and implementation of such activity can lead to unnecessary monetary loss, compliance issues and disruption in operation for both companies. This course will explore the types of technology transfers among companies and the issues affecting the transfer within and among companies, including the regulatory requirements that is associated with it. In order to cope with such movements, strategies justified with examples, will be explored.

Course Outline

• Pharmaceutical Product Life Cycle - Development, Innovation, Mature, Generic
• Product and Technology Transfers - Intellectual Property, Technology Transfer, Skills Transfer, Regulatory Considerations
• Benefits of Technology Transfer
• Registration Procedures
• Variation Procedures - Types of Variations, Advantages and Disadvantages
• Challenges
  o Technical Challenges - Manufacturing Process, Validation, Risk Management and Technology Transfer
  o Logistical Challenges
  o Human Challenges - Team Membership and Team Roles, Cross-Cultural Issues
• Approach to Successful Technology Transfers
  o Quality-by-Design (QbD)
  o Critical Process Parameters (CPP)

Learning Outcome

Upon completion of this course the attendees will be able to:

1. Appreciate where Technology Transfer will fit into the life cycle of a pharmaceutical product
2. Understand the regulatory requirements for technology transfers
3. Understand the importance of planning technology transfer and the requirements for successful technology transfers
4. Gain an understanding of the challenges faced in technology transfer



Fees & Funding

Please enquire below for course fees and financial grants:




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