Microbial Contamination Control in Bioprocessing Operations
Register for this course by selecting one of the dates above.
|10% Discussion/group activity|
|40% Hands-on lab experience|
|45% Fundamentals and concepts|
|50% Industry applications|
|5% Emerging technologies|
This course can count toward your Professional Certificate in Biomanufacturing Science.
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 and tea
- Afternoon beverage break
- Certificate of completion
Lucia Clontz, D. H.Sc., M.S., is the President, of Clontz Consulting, Inc. Formerly the site Quality Head for Xellia Pharmaceuticals in Raleigh, she has 30 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 served 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.
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If a course you want to take is already full, you are welcome to email firstname.lastname@example.org 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.
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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. Any additional discount questions prior to registration should be directed to Scott Latus at firstname.lastname@example.org.
Cancellation by registrant
To cancel a registration and be eligible for a refund of course fees, you must notify BTEC by email 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
Refunds will take 60–90 days for processing.
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 email 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.
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Once registered, confirmed course participants will receive a series of emails approximately three weeks before the scheduled course with detailed information regarding travel to BTEC, parking information, and a short pre-course questionnaire.