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Analytical Methods for Raw Materials Testing

Register for this course by selecting the above date.

Delivery methods

Course content

Why should you attend?

In this three-day course, you will learn how to find and interpret regulatory resources for raw materials testing, gain familiarity with harmonization, and learn how to assign risk to raw materials in biomanufacturing processes. Hands-on laboratory sessions will provide exposure to various analytical equipment and techniques often required by the United States Pharmacopoeia and European Pharmacopoeia for raw materials.

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 variation and require testing to ensure final product quality and safety. In this three-day course, participants will be introduced to the regulatory guidelines for assessing raw material risk, phase appropriate testing, and where to find this information. In addition, the course will focus on interpreting the different sections of both the United States and Pharmacopoeia and European Pharmacopoeia — from general chapters to monographs — and consider how to stay up to date with recent and upcoming changes. Laboratory activities will introduce participants to various analytical equipment and techniques often required by the pharmacopoeias for raw materials. The highlight of this course will be hands-on laboratory work in which participants will practice interpreting and executing analytical pharmacopoeial methods for some of the most ubiquitous biopharmaceutical raw materials and tests.

Attend and you will learn

  • To make general assessments regarding raw material risk and understand the regulatory guidelines that inform phase-appropriate testing
  • To navigate the US and European Pharmacopoeias
  • To interpret and execute common pharmacopoeial tests

Participants will also gain familiarity with various analytical equipment and techniques often required by the United States Pharmacopoeia and European Pharmacopoeia for raw materials.

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 in-depth 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
  • Lunch
  • Afternoon beverage break
  • Certificate of attendance

Instructors

Fee

$2,400


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 melody_woodyard@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 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 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 2% 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 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.