Technology Transfer

T2

Program

TBD AMERICAby

Barry Stevens, PhD

We are:

•an experienced global technology driven consulting firm specializing in the transfer for a full spectrum of technologies

•capable, methodical, flexible, and dedicated to our clients success and growth

•composed of a Team with proven field and operational experience with deep industry knowledge

Why TBD for T2

Anna Clark, LEED Keith Dackson, PhD, PE

Grant Harrell, MBA

Mark Hoy, MBAHenry KaChina & Asia

Konstantinos KlislarisEurope

Mark McHugh, BABrazil & South America

Steven Richardson, BA

Terry Roberts

Barry Stevens, PhD

• Transferred RCA’s revolutionary VideoDisc technology to CBS Record’s manufacturing plant.….. Started up production 4 months ahead of schedule and under budget

• Developed and transferred a sophisticated product development plan that affected over 5,000 items

….. Reshaped the entire development process between headquarters and offshore Offices in Japan, Hong Kong, Taiwan and Korea

….. Reduced time-to-market from 4 years to 1.5 years….. Helped jump annual sales by 10% ….. Reduced in-warranty repairs by 21.6% for a total annual savings of $23 million

• Developed and transferred into production CD-ROM technology for a Fortune 500 company….. 1985 , six years prior to market introduction

• Transferred a cutting-edge class III medical device from development to manufacturing p..... Started up production on schedule at the right quality and cost

T2 Accomplishments

• Best practice knowledge transfer / skills development

• Subcontracting arrangements

• Joint ventures

• Licensing of IP

• Subcontracting arrangements

• Equipment lease agreements

• Service agreements

• Others

T2 Program

Structures

to ensure the effective

and efficient transfer of a

robust and well

documented production

processes from

development to

manufacturing

T2 Goals

• Technology transfer team – T3

• Transfer document

• Production scale qualification

• Training development and

manufacturing

• Transfer project champion

• Formalized 3rd party communication

Elements for Improved Transfers from Development to Manufacturing

• Cross-func tional team representing all departments,

manufacturers, and suppliers involved

• Team requires appropriate resources and tools to

accomplish the task

• Train team on the technology transfer process

• Train team members on the use of the process tools (eg,

database) to help organize and assemble nu merical data,

assign action items, determine the current level of

readiness, and identify areas of weakness or omission

• Define and follow a reason able course of action

Technology transfer team – T3

Executive summary of transfer package

Product description

Product release specifications

Process description/characterization

Development batch records

Process development

Validation

Stability plan and data

Documentation

Successful start-up of a

new production facility is

the objective of every

new facilities project.

Production Scale Qualification - Goal

•Practice’ runs following mechanical completion and validation

•The production scale qualification (PSQ) lots are not necessarily intended to be consistency lots, thus increasing the flexibility for making necessary improvements to SOPs and batch records.

•PSQ lots are performed for every new process introduction, or when there has been a major process change, immediately following the traditional installation qualification (IQ), operational qualification (OQ), and process qualification (PQ) validation procedures.

•The PSQ lots are done under full ISO production conditions, with fully signed SOPs and batch records, in fully validated (IQ, OQ, PQ) equipment and facilities, with fully released raw materials, and full QC testing with validated testing protocols.

Production Scale Qualification - Formalization

•Effective training of all involved in the new process, from management to line operators is essential to project success.

•Generally, training is initiated during validation activities (IQ, OQ, PQ) and completed during PSQ. All training is documented, and involves identified members of all relevant departments.

•Tools Procedures, story board, flow charts Review and check lists SOP O.J.T. Test and Certify

Training Development and Manufacturing

•Consistent leadership throughout the technology transfer process is an important aspect of success.

•The product transfer champion is a person in manufacturing or development with overall responsibility to move the project forward and the personal and managerial commitment to carry it through to completion.

•As leader of the technology transfer team, the project transfer champion is required to take a proactive role by directing the technology transfer team through technical and managerial difficulties, and by presenting the progress and needs of the project to the organization to ensure the availability of required resources.

•The project transfer champion requires a high level perspective of the process, knowledge of project status, and skill in communicating with the organization.

Transfer Project Champion

Early in the process of transfer from development to manufacturing, but after firm facilities plans have been established, it is highly desirable to have an informational meeting with appropriate 3rd party representatives.

Formalized 3rd Party Communication

This T2 process gives a structure for the measurement of compliance at various stages of transfer, allowing corrective action to be taken before major difficulties arise.

In each of the six steps, the technology transfer team can review the situation to-date in a given project, and compare the observed situation to the expected result defined by this process.

Summary

Questions

Contact Us, see next page

Barry Stevens, PhD

President

TBD America, Inc.

2007 Thames Drive

Arlington, TX 76017

LandLine: +1 817.465.2228

Fax: +1 817.465.2228 (prior notification)

Cell: +1 817.366.4537

Skype: barrystevens58

Email: barry@tbdamericainc.com

Website: www.tbdamericainc.com

Contact Information