Creating a Resilient & Robust Contamination Control Strategy

Creating a Resilient & Robust Contamination Control Strategy

In the current regulatory landscape, a Contamination Control Strategy (CCS) is more than a document; it is a holistic, "living" systematic approach. This presentation moves beyond theoretical frameworks to provide a blueprint for a robust CCS that safeguards both patient safety and operational continuity.

We will examine the design of an effective CCS, emphasizing the shift from reactive testing to proactive, risk-based prevention. However, even the most rigorous systems face challenges. We will provide a deep dive into the "anatomy of a response," detailing how to execute through strategic investigations, implement effective remediation, and—most critically—leverage data from contamination events to strengthen your CCS against future vulnerabilities.

The evening includes Dinner and Networking to connect with fellow Pacific Northwest biotech professionals and innovative local vendors.

Key Takeaways

• The Holistic Blueprint: Learn to integrate fragmented controls into a unified, site-wide CCS that satisfies global regulatory expectations.
• Successful Remediation: Understand investigation and response techniques specifically tailored for contamination events to ensure remediation is permanent, not performative.
• The Continuous Improvement Loop: Discover how to transform investigation findings into strategic updates, evolving your CCS to prevent future contamination events.

Who Should Attend?

• Quality Assurance & Quality Control Professionals
• Manufacturing & Operations Specialists & Leadership
• Microbiologists, Contamination Control, & Environmental Monitoring Leads
• Facility Engineer Specialist & Leadership
• Regulatory Affairs Specialists

Date: Tuesday, April 07, 2026

Doors Open: 5:30 pm

Location: Kenmore Community Club, 7304 NE 175th St, Kenmore, WA 98028

Don't miss this unique chance to connect with peers and expand your knowledge. Space is limits so register now to secure your spot!

Sr. Microbilogy Consultant, ValSource, Inc.

James is a Senior Microbiology Consultant who brings over 20 years of experience in clinical and commercial drug-substance and drug-product facilities to the pharmaceutical manufacturing industry. He specifically focuses on contamination control strategy development, facility and process design, airflow visualization studies, aseptic processing, cleaning and disinfection, environmental monitoring, and training development and delivery. James is also passionate about educating others in the industry by teaching multiple courses and course segments at PDA’s Training and Research Institute, covering subjects such as Airflow Visualizations, Environmental Monitoring, Aseptic Processing Simulations, and Contamination Control Strategies. He is also a Member-at-Large for the PDA Southeast Chapter.

With a commitment to advancing aseptic techniques and microbiological safety, James continues to support clients in achieving operational excellence in pharmaceutical manufacturing.

Almac Clinical Services have been partnering with clients for 30+ years, we set the standard for developing effective supply chain strategies that ensures our sponsors can overcome their unique challenges and deliver supply continuity to patients wherever they are in the world.

We have a range of tools and services to help you achieve this, from forecasting/inventory management, supply chain strategy to global logistics management, end-to-end temperature solutions, IRT set-up and strategy, direct to patient distribution and Ph*rm*cy services alongside our clinical packaging and labelling facilities.

When you partner with Almac you are partnering with experts who Supply With Care™.

LinkedIn: https://www.linkedin.com/company/almac-group/

Email: Michael Hurley - [email protected]

Fisher Scientific, a division of Thermo Fisher Scientific, provides an extensive range of laboratory equipment, life sciences supplies, safety products, and facility management solutions to support research, production, healthcare, and science education sectors. We keep science moving forward by offering over 2.5 million products and extensive support services to the research, production, healthcare, and science education markets around the world.

LinkedIn: https://www.linkedin.com/company/fisherscientific/

Email: Theresa Hoenes – [email protected]

ValSource provides a wide range of consulting, commissioning, and validation services that make pharma, biopharma, and medical device organizations even more successful. We are experts in navigating regulated industries and the rigorous requirements that accompany them. Ensure speed-to-market success and eliminate risk with our complete line of services and our experienced staff by your side – from start to finish.

LinkedIn: https://www.linkedin.com/company/valsource-inc/posts/?feedView=all

Email: [email protected]

Velteck Associates, Inc. (VAI’s) manufacturing & testing operations mirror current GMP/GLP standards. With more than 35 years of contamination control experience, their products and services include a comprehensive line of disinfectants, sporicides, residue removers, process cleaners, quality water, saturated and dry wipes, disposable garments, cleanroom paper, documentation materials, RFID tracking systems, printing systems, viable monitoring, cleanroom cart systems, cleaning equipment, consulting, and laboratory services.

LinkedIn: https://www.linkedin.com/company/veltek-associates-inc/

Email: [email protected]

Particle Measuring Systems partners with clean manufacturers around the world to help meet regulatory requirements, improve product yield, and maintain process integrity. Our goal is to lead in contamination monitoring – enabling​ clean manufacturers​ through cutting-edge technology, unmatched service, and the dedication​ of our global team.​ We deliver contamination monitoring solutions for particles and molecules across air, gas, chemicals, and deionized water, along with active air microbial samplers.

LinkedIn: https://www.linkedin.com/company/particle-measuring-systems/

Email: Tessa Thorp – [email protected]

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