Microbial Contamination Control in Bioprocessing Operations
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|10% Discussion/group activity|
|40% Hands-on lab experience|
|45% Fundamentals and concepts|
|50% Industry applications|
|5% Emerging technologies|
Why should you attend?
Gain a fundamental understanding of sources of microbial contamination in biopharmaceutical manufacturing. Learn how to evaluate contamination risks and implement corrective and preventative measures to ensure a state of microbiological control in facilities and processes. Learn about recent regulatory expectations for control of contamination.
Attend and you will learn
- Potential sources of microbial contamination
- Regulatory expectations for a contamination control strategy
- Best practices in management of microbial contamination, to include monitoring programs for detection of bioburden and endotoxin
- Best practices in equipment, process, and facility design
- Risk assessment applied to control of contamination
- Best practices in sanitization and disinfection
Who should attend
Professionals responsible for any aspects of microbial control who work in the following areas:
- Quality Assurance
- Quality Control
- Regulatory Assurance
- Process and Cleaning Validation
- Equipment Qualification and Maintenance
- Engineering – Facility and Systems Design
Attend and you will receive
- 21 hours of instruction (2.1 Continuing Education Units)
- Notebook containing all course lecture and lab materials
- Morning coffee
- Afternoon beverage break
- Certificate of attendance
Lucia Clontz, D. H.Sc., M.S., is the Site Quality Head for Xellia Pharmaceuticals in Raleigh. She has more than 26 years of industry experience in quality, pharmaceutical microbiology, laboratory management, operational excellence initiatives, and training. She is a published author, speaker and workshop leader at both national and international conferences, and in 2004, she received the Parenteral Drug Association's Distinguished Editor/Author award. She currently holds an appointment as a BTEC Teaching Fellow and also serves as a member of the United States Pharmacopeia (USP) Pharmaceutical Waters Expert Panel (2010-2015).
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.
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 email@example.com to make arrangements immediately after registering and note the following:
- If you wish to pay by company check or wire transfer, please note that payment is due within 10 days of registration and seats can not be held longer without payment or confirmation of a pending payment.
- If your company requires an invoice for processing, and the invoice needs to reference a PO number, please include the PO number in your email. Please note that a PO number will not hold a seat.
- If you wish to pay by wire transfer, please note that BTEC will add a 2% wire transfer fee to the total cost of the course.
- If no payment arrangements/confirmations have been received within 10 business days of registration, BTEC reserves the right to cancel registration based on enrollment demand.
Any additional questions prior to registration should be directed to firstname.lastname@example.org.
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
- Society of Industrial Microbiology and Biotechnology (SIMB) members
A 30% discount is available to faculty/staff working in academic environments.
Check out BTEC’s professional development certificate program for an additional way to save money on short course costs.
Short course cancellations
Cancellation by registrant
To cancel a registration and be eligible for a refund of course fees, you must notify BTEC by e-mail to email@example.com 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 firstname.lastname@example.org. 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.
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 email@example.com to confirm your registration.
Once registered, confirmed course participants will receive an email approximately two weeks before the scheduled course with detailed information regarding travel to BTEC, parking information, and a short pre-course questionnaire.