Hands-On cGMP Biomanufacturing Operations

Delivery methods

35% Lecture

10% Discussion/group activity

55% Hands-on lab experience

Course content

10% Fundamentals and concepts

80% Industry applications

10% Emerging technologies

Upstream

Downstream

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 and tea
Lunch
Afternoon beverage break
Certificate of completion

Instructors

Fee

$3,995

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.

If a course is full: Waitlist policy

If a course you want to take is already full, you are welcome to email mswoodya@ncsu.edu and ask to be placed on a waitlist for that course. The waitlist is used to fill any seats that become available when individuals registered for the course are unable to attend. If one or more seats become available, individuals on the waitlist are contacted in the order in which they were added to the list.

In addition to ensuring popular courses remain full, waitlists provide a means of tracking interest and determining if additional sessions are necessary. BTEC makes every effort to schedule additional course offerings if sufficient people are wait-listed. If a new offering is scheduled, those on the waitlist are notified before registration opens to the public.

Placement on a waitlist does not commit individuals to attending a course. It simply ensures that they are given first opportunity to enroll if a seat becomes available in a full course and that they are among the first to know if an additional course offering is scheduled during the current year.

BTEC is unable to provide information about the number of those wait-listed for any given course or an individual's place on such a list.

Payment

BTEC requires payment by credit card at the time of registration. BTEC accepts payment from all major credit cards including American Express, Visa, and MasterCard.

After registration, a payment receipt is automatically emailed. If you do not receive the email, please check your spam folders.

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

Discounts available

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

Check out BTEC’s professional development certificate program for an additional way to save money on short course costs. Any additional discount questions prior to registration should be directed to Serena Hodge, Industry Training Coordinator, at shodge@ncsu.edu.

Cancellation policies

Cancellation by registrant

To cancel a registration and be eligible for a refund of course fees, you must notify BTEC by email to mswoodya@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

Refunds will take 60–90 days for processing. Refunds requested more than 90 days after payment will be issued as a check.

Substitutions may be made up to two business days prior to the course start date. Notify the BTEC office by email to mswoodya@ncsu.edu or by fax at 919-513-1697. 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 mswoodya@ncsu.edu to confirm your registration.

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

Content

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