Content

Microbial Contamination Control in Bioprocessing Operations

  • TBD

Delivery methods

Course content

analytical course

Special Topics

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 expectation for a risk-based Contamination Control Strategy (CCS).

Attend and you will learn

  • Potential sources of microbial contamination
  • Regulatory expectations for a contamination control strategy, including discussions on the revised (2022) EU GMP Guide Annex 1, effective August 25, 2023
  • 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
  • Manufacturing

Attend and you will receive

  • 21 hours of instruction
  • Notebook containing all course lecture and lab materials
  • Morning coffee and tea
  • Lunch
  • Afternoon beverage break
  • Certificate of completion

Instructor

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 37 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 serves as a member of the United States Pharmacopeia (USP) Pharmaceutical Waters Expert Panel (2010–2025).

Fee

$2,975

Important Information for In-person Course Participants

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