Universal Technology Transfer Methodologies for Biopharmaceuticals

COURSE DESCRIPTION
Discover how to set-up a team of professionals essential for the success of tech transfer.  Assess feasibility, business, and regulatory impact.  Identify necessary actions and create detailed assay and process transfer plans.  Monitor, evaluate progress, and manage proactively the ongoing technology transfer project.  Define criteria and document success of the technology transfer.  Defend the rationale for and the outcome of the transfer in front of US and international regulatory bodies.

INSTRUCTORS
Stephen M. Perry, PMP, Kymanox
Vladimir Kostyukovsky, Ph.D., Kymanox

COST
$990

DATES
November 2-3, 2009 8:30 AM – 4:30 PM  OR
March 15-16, 2010 8:30 AM – 4:30 PM

WHERE
Room 123 at BTEC,
850 Oval Drive
Raleigh, NC 27606

PDF INFORMATIONAL DOCUMENTS
Course Description
Course Summary
Course Agenda
BTEC Information Sheet

COURSE DETAILS

Why Should You Attend?	Every time your organization is contemplating to move a process or product from one location (e.g. lab, manufacturing facility, country, etc.) to another, you enter the domain of technology transfer.  The process is complex with multiple steps performed in a specific order, requiring significant resource commitments from many different groups in the organization for activities spanning from a few weeks to many months.  All of this calls for comprehensive planning, effective coordination, and first-time-right execution, often on very aggressive timelines.  By following the procedures and using the tools and templates provided, this course will allow you to avoid costly and often irreversible errors and to be successful, while being in control of schedule and budget.
Attend and You Will Learn	By the end of this course, students will be able to: Set-up a team of professionals essential for the successful tech transfer. Assess feasibility, business, and regulatory impact. Identify necessary actions and create detailed assay and process transfer plans. Monitor, evaluate progress, and manage proactively the ongoing technology transfer project. Define criteria and document success of the technology transfer. Defend the rationale for and the outcome of the transfer in front of US and international regulatory bodies.
Who Should Attend	Anyone involved in moving analytical assays and/or manufacturing processes internally or externally, in early development, for clinical or commercial manufacturing, including but not limited to professionals from the following functional areas: Process Development Manufacturing Sciences Quality Assurance and Regulatory Quality Control Manufacturing Validation Process Engineering Business Development Project Management
Attend and You Will Receive	Four in-depth lectures on the specifics and mechanics of technology transfer Examples of real-life industry cases Detailed list of documents and tools required for technology transfer with samples and editable templates based on best industry practices Access to instructors with first‐hand technology transfer experience Support of capable Kymanox staff for all of your technology transfer and technical project management needs

SIGNUP

There are two ways to sign up:

Signup for the November 2-3, 2009 session on our KymaSTORE website using your credit card.
Signup for the March 15-16, 2010 session on our KymaSTORE website using your credit card.

OR

REGISTRATION EMAIL/ CHECK

Send an email to reserve your seat to info@kymanox.com with your name, phone number, email and the session you would like to attend.

Mail your check for $990 to:

Kymanox
Attn: Course Coordinator
2220 Sedwick Road, Suite 201
Durham, NC 27713

Questions? Please call Kymanox at: +1-919-246-4896

"Small projects need much more help than great ones." - Dante Alighieri