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Applied Cleaning Validation Practices: A STERIS Master Class

  • March 6–7, 2024

Delivery methods

Course content

Why should you attend?

This two-day intensive course presented by invited industry experts covers industry practices, 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 addresses several current challenges to cleaning and validation in the biopharmaceutical industry and includes case studies, best practices, and hands-on exercises using state-of-the-art bioprocessing equipment located in the BTEC facility. The course covers numerous topics, including the following:

  • Lifecycle approach to cleaning validation
  • Cleaning chemistries and 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 coffee and tea
  • Lunch
  • Afternoon break
  • Certificate of completion

Instructors

Antonio Ortiz has over 18 years of experience in research and development, technical transfer, process and cleaning validation, regulatory submissions, and Good Manufacturing Practices (GMP) manufacturing troubleshooting and investigations. He holds a master’s degree in biomedical engineering and a bachelor’s degree in chemical engineering. Prior to joining STERIS Life Sciences, Antonio spent time at Stryker, Bausch + Lomb, Catalent and Apotex in positions including Validation Engineer, Process Engineer, and Technical Services Scientist. Antonio provides technical support to STERIS Life Sciences Customers by integrating multiple areas of specialization to resolve complex pharmaceutical and biopharmaceutical challenges. He also administers global pharmaceutical and biopharmaceutical industry education programs and presents at industry conferences. Antonio is an active member of the International Society for Pharmaceutical Engineering (ISPE) and the Parenteral Drug Association (PDA).

Brian Bosso is a Technical Services Manager for STERIS Life Sciences. He has responsibility for providing global technical support for pharmaceutical detergents and critical environment products and their application and validation. Brian has over 13 years of experience in the pharmaceutical and biopharmaceutical industries having previously worked at Sandoz, Aldevron, and as an onsite consultant on projects in North America, Europe, and Asia. He has held supervisory and management positions with responsibilities in areas including developing and implementing cleaning validation process lifecycle, process design, analytical method development, GMP quality and regulatory remediation. He earned a Bachelor of Science degree in chemistry from the Colorado School of Mines.

Paul Lopolito is a technical services senior manager for the Life Sciences Division of STERIS Corporation. He currently provides global technical support related to process research cleaners and contamination control, which includes field support, site audits, training presentations and educational seminars. Paul has over 20 years of industry experience and has held positions as a technical services manager, manufacturing manager and laboratory manager. He is a frequent speaker at industry events including the PDA, ISPE, INTERPHEX, ACHEMA, AALAS, LAMA, and IVT. Paul has published several articles and book chapters related to cleaning and cleaning validation. He earned a Bachelor of Arts in biological sciences from Goucher College in Towson, Md.

Fee

$2,000


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 mswoodya@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 requires payment by credit card at the time of registration. BTEC accepts payment from all major credit cards including American Express, Visa, and MasterCard.

After registration, a payment receipt is automatically emailed. If you do not receive the email, please check your spam folders.

Any additional questions prior to registration should be directed to mswoodya@ncsu.edu.

Discounts available

A 20% discount is available for NIIMBL members for the following courses:

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 Serena Hodge, Industry Training Coordinator, at shodge@ncsu.edu.

Cancellation policies

Cancellation by registrant

To cancel a registration and be eligible for a refund of course fees, you must notify BTEC by email to mswoodya@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

Refunds will take 60–90 days for processing. Refunds requested more than 90 days after payment will be issued as a check.

Substitutions may be made up to two business days prior to the course start date. Notify the BTEC office by email to mswoodya@ncsu.edu or by fax at 919-513-1697. 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 mswoodya@ncsu.edu to confirm your registration.

Once registered, confirmed course participants will receive a series of emails approximately two weeks before the scheduled course with detailed information regarding travel to BTEC, parking information, and a short pre-course questionnaire.