Technology Transfer

העברת טכנולוגיות
מרצה: Dr. Malcolm Ross

תאריך: 30, 31 מרץ 2016
מיקום הקורס: כפר המכביה, רמת גן
מידע כללי
משך הפעילות: 2 ימי לימודים מלאים
שעות:  09:00-17:00
עלות: 4,300 ש"ח + מע"מ
נקודות זכות: 2
מק''ט: 16226
שפת הקורס: עברית
על הקורס
העברת טכנולוגיות אמורה להתבצע ללא תקלות אלא שמצב אידיאלי זה כמעט ואינו מתרחש. יש איפוא לפעול לצמצם עד למינימום את התקלות האפשריות ע"י תכנון נכון של התהליך כבר מראשיתו. במסגרת הקורס יובהר מהן הסיבות להיווצרותם של התקלות לאורך התהליך של העברת טכנולוגיות ואילו מערכות יש להפעיל כדי למנוע אותם. יוצגו טיפוסים שונים של העברת טכנולוגיות, כולל טכניקות לביצוע התהליך ופתרונות יישומיים להקמת הצוותים המתאימים ולביצוע תהליכי העבודה הנדרשים.

There are many times that companies are involved in the transfer of technology. These may be external, as in outsourced work or in-licensing, or internal as in the transfer from research and development to production or from analytical development to quality control. With the increased activity in M & A in both the branded and the generic industry and the decision of many of the major innovator companies to outsource their production, the need for technology transfer is ever increasing.

However, most companies have not restructured their organisations to deal with this increased activity and as a consequence have problems in making these transfers, both in terms of quality or in timelines. These problems range from minor annoyances, through  reduced profitability and even complete failure.

The ideal Technology Transfer should be seamless-that is there should be zero problems but this almost never happens.However these problems can be minimal if the process is planned from the beginning rather than just being allowed to happen.

This course will show why problems occur and how they can be avoided if the correct systems are put in place at the right time. It will look at various aspects of different types of transfer and what systems are needed to be put in place.

It will look at how to plan for technology transfer and will look at both technical and project management techniques which will reduce the difficulties. It will deal with the difficulties of communicating between parties involved and the different philosophies in R&D and production. Concrete proposals will be made as to how to set up a technology transfer group and to create a technology transfer charter or protocol.

The course will be illustrated with many real examples from areas of pilot and scale up of chemical synthesis, transfer of finished dosage forms from Pharmaceutical Development to Production and the transfer of analytical methods from R&D to QC.

קהל היעד
  • Project managers
  • Planners & production technologists
  • Analytical chemists and development scientists involved in transferring or receiving technology or methods
  • Business Development staff involved in licensing technologies.
Technology Transfer
התועלת שתופק

Participants will come away with an understanding of the Technology Transfer process and how the success of this is dependent on both soft and hard skills. They will learn that Tech Transfer is a project like any other project and as such need to be managed and some fundamental rules of project management will be demonstrated in the context of Tech Transfer.

From the technical viewpoint participants will be taught to look at their products and processes from a risk management point of view and thus concentrate on the high risk areas involved in transferring a product, process or analytical procedure.

In addition, some of the newer concepts such as design space, Quality by Design and PAT will be discussed to allow participants to consider the potential introduction of “Tech Transfer by Design”

השאר פרטים למידע נוסף
  • שם מלא
  • דוא''ל
  • טלפון
  • הערות
  • שלח
תכני הקורס

PART 1-INTRODUCTION
An overview of  technology transfer and the points in a product life cycle where these transfers are required.
An analysis of tech transfer in terms of project management and the establishment of a technology transfer charter.

PART 2-TYPES OF TRANSFER
Transfer technology in different environments such as internal or external, or between development and production as compared to production to production at a different site. Some legal and contractual issues related to internal transfers compared to external transfers with particular reference to IP, quality and liability.

PART 3-TRANSFER MANAGEMENT
Setting up a transfer technology team. Maintaining team motivation. Cultural differences and their effect on the transfer processes.

PART 4-TECHNICAL ISSUES
A discussion of various technical issues such as non compatibility of equipment and detailed examples showing where things can go wrong and how to avoid them

PART 5-REGULATORY ISSUES AND QbD
Regulatory aspects related to transfers and the importance of quality by design in providing rugged processes

PART 6-TECH TRANSFER OF ANALYTICAL METHODS
Consideration of why analytical methods do not transfer in a seamless manner. How the differences in equipment and in philosophy affect the transfer

אודות המרצה

Dr. Malcolm Ross

Dr. Malcolm Ross is a consultant specialising in training, project management and research and development in the pharmaceutical industry.
He holds a B.Pharm and Ph.D in medicinal chemistry from London University, was a lecturer at the Welsh School of Pharmacy, UWIST and a Visiting Senior Lecturer in the Dept. of Chemistry at Bar Ilan University and is a registered pharmacist in the State of Israel.
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