Analytical Methods for Raw Materials Testing
|20% Discussion/group activity|
|50% Hands-on lab experience|
|30% Fundamentals and concepts|
|60% Industry applications|
|10% Emerging technologies|
This course can count toward your Professional Certificate in Biomanufacturing Science.
Why should you attend?
Biopharmaceutical manufacturing relies on a wide variety of raw materials, including ancillary reagents for cell culture, components for purification, excipients for formulation, and materials for container/closure and storage. Many of these materials are a potential source of process and/or product variation and require testing to ensure final product quality and safety.
This three day course will provide hands-on training for the most common raw materials testing techniques with specific focus on Inductively Coupled Mass Spectrometry (Chapters <232> and <233>, Elemental Impurities by ICP-MS). Additional laboratory sessions will include the following:
- Identification (ID) by handheld Raman, ID by FTIR (Chapter <197> Spectroscopic Identification Tests),
- Water content via loss on drying and Karl Fischer (Chapter <921> Water Determination),
- Endotoxin testing (<85> Bacterial Endotoxins), and
- Various titrations (Chapter <541> Titrimetry).
These laboratory exercises will focus on interpretation of the United States Pharmacopoeia (USP) — from general chapters to monographs — and how to stay up to date with recent and upcoming changes. Participants will also be introduced to the regulatory guidelines for raw material testing, assessing raw material risk, and phase appropriate testing.
Attend and you will learn
- To perform the most common USP raw materials tests: Elemental Impurities (ICP-MS), ID (Raman and FTIR), Water Content (LOD and KF), Bacterial Endotoxins, and Titrimetry.
- To navigate the US Pharmacopoeia and other regulatory guidelines
- To make general assessments regarding raw material risk and understand phase-appropriate testing
Who should attend
This course is intended for biopharmaceutical quality control and quality assurance personnel as well as scientists working with raw materials release who want an understanding of risk assessment and an introduction to an analytical lab experience. Others who may benefit from this course include vendors and suppliers of biological raw materials as well as graduate students and faculty working in the areas of materials identification and quality assessment.
Attend and you will receive
- 21 hours of instruction
- Notebook containing all course lecture and lab materials
- Morning coffee
- Afternoon beverage break
- Certificate of attendance
Interested in attending?
Please complete this short form to be notified when registration is available.
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 email@example.com 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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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 firstname.lastname@example.org to make arrangements immediately after registering and note the following:
- If you wish to pay by PO or company check, 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 $75 processing fee to the total cost of the course for all PO or company check payments.
Any additional questions prior to registration should be directed to email@example.com.
A 20% discount is available for select courses 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. Any additional discount questions prior to registration should be directed to 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 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.
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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.