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Hands-On cGMP Biomanufacturing Operations

2020

Register through our online system by selecting the link above.

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This course can count toward your Professional Certificate in Biomanufacturing Science.

Why should you attend?

To obtain a basic knowledge of biomanufacturing operations and how cGMP requirements are implemented at commercial scale. Engage in pilot-scale laboratory experiences that examine process utilities, media and solution preparation, bioreactor operation, centrifugation, chromatography, and tangential flow filtration in a simulated commercial cGMP (current Good Manufacturing Practice) facility.

Attend and you will learn

  • How cGMP expectations are met in a biomanufacturing facility
  • How clean process utilities are produced
  • To prepare sterile fermentation media and solutions required for downstream processing
  • To clean, prepare, and operate bioreactors, centrifuges, chromatography systems, and tangential flow filtration systems
  • Basic principles underlying the unit operations for production of biologics
  • How to monitor and/or manipulate control parameters that result in a process that meets production expectations

Who should attend

Anyone interested in obtaining a basic knowledge of large-scale biomanufacturing operations and applying that knowledge in a simulated cGMP environment, such as the following:

  • New biomanufacturing employees, including scientists and engineers
  • Biomanufacturing support personnel who may not be directly involved with the process they support
  • Vendors who supply the biomanufacturing industry with equipment and components
  • Incumbent workers looking to enter the biomanufacturing industry

Attend and you will receive

  • 30 hours of instruction (3.0 Continuing Education Units)
  • Notebook containing all course lecture and lab materials
  • Morning coffee
  • Lunch
  • Afternoon beverage break
  • Certificate of attendance

Instructors

Gary Gilleskie, Ph.D., Charles Rutter, Ph.D., and Krisstina Burgess, Ph.D.

Fee

$3,200


Location

All courses are offered on site at BTEC, other than online courses. The Golden LEAF BTEC building is located at 850 Oval Drive on NC State University's Centennial Campus.

Payment

BTEC strongly prefers payment by credit card at the time of registration. BTEC accepts payment from all major credit cards including American Express, Visa, and MasterCard. If you are not paying by credit card at the time of registration, please email melody_woodyard@ncsu.edu to make arrangements immediately after registering and note the following:

  • If you wish to pay by PO, company check, or wire transfer, please note that payment is due within 10 days of registration. If paying by PO, please reference PO number in your email, but note that a PO number will not hold a seat.
  • If no payment has been received within 10 business days of registration, BTEC reserves the right to cancel registration based on enrollment demand.
  • BTEC will add a 2% processing fee to the total cost of the course for all PO, company check, or wire transfer payments.

Any additional questions prior to registration should be directed to melody_woodyard@ncsu.edu.

Discounts available

A 20% discount is available to:

  • Employees of BMF companies
  • Groups of five or more from one company registering for the same offering of this course
  • Individuals registering for more than one course at a time
  • Faculty/staff working in academic environments

A 40% discount is available for NIIMBL members for the following courses:

  • Hands-On cGMP Biomanufacturing of Vectors for Gene Therapy
  • Hands-on Essentials of Automation for Biomanufacturing

Check out BTEC’s professional development certificate program for an additional way to save money on short course costs.

Cancellation policies

Cancellation by registrant

To cancel a registration and be eligible for a refund of course fees, you must notify BTEC by e-mail to melody_woodyard@ncsu.edu or fax to 919-513-1697. Fees are refunded according to the following schedule:

  • 100% refund – If notification is received at least 15 business days in advance of course start date
  • 75% refund – If notification is received 10–14 business days in advance of course start date
  • 50% refund – If notification is received 6–9 business days in advance of course start date
  • No refund will be issued if notice is received 5 or fewer business days in advance of course start

Substitutions may be made up to two business days prior to the course start date. Notify the BTEC office by fax at 919-513-1697 or by e-mail to melody_woodyard@ncsu.edu. Please include the name and email contact for the replacement. Please note that BTEC is unable to honor substitutions for individuals taking discounted courses as part of the professional development certificate program.

Cancellation by BTEC

BTEC retains the right to cancel a professional development short course no less than 10 business days in advance of the scheduled course start date. Registrants will be notified by BTEC if a course is cancelled and will receive a full refund of registration fees paid. BTEC is not responsible for airfare penalties or other costs incurred due to cancellation.

Pre-Course Communication

Upon successful registration for a course, you will receive an automatically-generated email as well as another email from Melody Woodyard confirming your registration. If you do not receive these emails within two business days of registering for a course, please email melody_woodyard@ncsu.edu to confirm your registration.

Once registered, confirmed course participants will receive an email approximately three weeks before the scheduled course with detailed information regarding travel to BTEC, parking information, and a short pre-course questionnaire.