Applied Cleaning Validation Practices: A STERIS Master Class
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
| 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 |
Register by May 19
Attend and you will learn
- 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
Delivery methods
45% Lecture
40% Discussion/group activity
15% Hands-on lab experience
Course content
20% Fundamentals and concepts
70% Industry applications
10% Emerging technologies
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.
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.
Dijana Hadziselimovic is a Manager, Laboratory Technical Services for STERIS Life Sciences. Dijana has over two decades of laboratory experience in the pharmaceutical and biotechnology industries. She provides technical support for process and research cleaners, stainless steel maintenance, cleaning validation, and conducts laboratory experiments to recommend cleaning procedures. She holds a bachelor’s degree in chemistry. During her time at STERIS Life Sciences, Dijana has developed expertise in cleaning validation, cosmetics and personal care, manufacturing cannabis-derived products and oral solid dose manufacturing. Dijana served as Chair-Elect for the St. Louis Society of Cosmetic Chemists in 2016 and as Chair in 2017. She remains active with the organization and is also a member of the International Society for Pharmaceutical Engineering (ISPE), the Institute of Environmental Sciences and Technology (ESTECH) and the International Federation of Societies of Cosmetic Chemists (IFSCC). Dijana has been a PDA member since 2022.