Microbial Contamination Control in Bioprocessing Operations
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).
| Dates | Course | Cost | Registration |
|---|---|---|---|
| May 12-13, 2026 | Artificial Intelligence in FDA-Regulated Manufacturing: From Foundations to Implementation | $1,500 | Register |
| May 20–21, 2026 | Hands-On Essentials of Automation for Biomanufacturing | $2,050 | Register |
| May 27–29, 2026 | Preparative Chromatography Column Packing: Lab to Process Scale | $2,500 | Register |
| June 3–4, 2026 | Applied Cleaning Validation Practices: A STERIS Master Class | $2,000 | Register |
| June 9–10, 2026 | Introduction to Biopharmaceutical Lyophilization | $1,975 | Register |
| June 11, 2026 | Essentials of Spray Drying and Powder Analysis | $995 | Register |
| June 16–18, 2026 | Fundamentals of Mammalian Cell Line Development | $3,100 | Register |
| June 23–25, 2026 | Biopharmaceutical Assay Essentials | $3,100 | Register |
| June 23–25, 2026 | Fermentation Engineering | $3,100 | Register |
| June 30–July 2, 2026 | Hands-On Principles of mRNA Technology | $2,500 | Register |
| July 8–10, 2026 | Downstream Biopharmaceutical Processes: Fundamentals and Design | $3,100 | Register |
| July 14–16, 2026 | AAV Quality Attributes: Theory and Practice | $2,975 | Register |
| July 14–17, 2026 | Hands-On cGMP Biomanufacturing Operations | $4,200 | Register |
| July 28–31, 2026 | Hands-On Biomanufacturing of Vectors for Gene Therapy | $4,500 | Register |
| Aug 6, 2026 | Design of Experiments for Biomanufacturing | $500* | Register |
| Sept 29–Oct 1, 2026 | Cell Culture Engineering | $4,200 | Register |
| Oct 13–16, 2026 | Applied Principles and Techniques of Depth Flow Filtration (DFF) and Tangential Flow Filtration (TFF) for BioPharm Purification | $3,995 | Register |
| Nov 10–12, 2026 | PAT for Real-time Culture Monitoring and Closed-Loop Process Control | $2,975 | Register |
| November 12-19 | Microbial Contamination Control in Bioprocessing Operations | $2,975 |
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
Delivery methods
50% Lecture
10% Discussion/group activity
40% Hands-on lab experience
Course content
45% Fundamentals and concepts
50% Industry applications
5% Emerging technologies
21 hours of instruction
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
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).