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Applied Cleaning Validation Practices: A STERIS Master Class

July 17–18, 2018

Delivery methods

Course content

Why should you attend?

This 2-day intensive course presented by invited industry experts will cover industry practices and regulatory expectations and trends in cleaning and cleaning validation.  It is designed for biopharmaceutical manufacturers who are concerned about developing or maintaining a high-quality, efficient, and most importantly, compliant cleaning process. The training will address several current challenges to cleaning and validation in the biopharmaceutical industry, and include case studies, best practices, and hands on exercises using state-of-the-art bioprocessing equipment located in the BTEC facility. The course will cover numerous topics including:

  • Lifecycle approach to cleaning validation
  • Cleaning chemistries & application parameters
  • Laboratory studies and scale up
  • CIP, COP, Manual cleaning methods
  • Process and engineering Issues
  • Cleaning process equipment-bioreactors, rings, membranes
  • Cycle development
  • Process design and qualification
  • Setting acceptance criteria
  • Rinse and swab sampling
  • Analytical methods and validation
  • Protocols, grouping strategies
  • Dedicated equipment and campaigns
  • Continuous improvement
  • Stainless steel maintenance
  • Bioburden and biofilms
  • Global regulatory documents and citations

Attend and you will

  • Develop effective cleaning procedures that are able to be validated
  • Develop troubleshooting skills to address cleaning challenges
  • Understand issues to consider and gain practical insight into swabbing, analytical methods, identifying worst case locations, and issues associated with cleaning validation
  • Perform cleaning validation residue limits calculations
  • Integrate chemistry, microbiology, engineering, and validation principles in performing risk assessments
  • Understand regulatory expectations and best practices

Who should attend

Scientists and engineers working in the Biomanufacturing industry including roles such as Quality Assurance, Regulatory, Quality Control, Validation, Operations, Microbiology, Facilities Maintenance, Engineering, and Plant Management disciplines.

Attend and you will receive

  • Notebook containing all course lecture and lab materials
  • Morning break
  • Lunch
  • Afternoon break
  • Certificate of attendance

Fee

$1,350


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.

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 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 melody_woodyard@ncsu.edu.

Discounts available

A 20% discount is available to:

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 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 two weeks before the scheduled course with detailed information regarding travel to BTEC, parking information, and a short pre-course questionnaire.