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CO-LOCATED EVENTS

Speaker

Madison Summers

Manufacturing Technical Writer, Simtra BioPharma Solutions

Technical writer and quality professional focused on clear, consistent communication in regulated environments. I specialize in deviation investigations, CAPA reporting, and continuous improvement documentation—translating technical findings into actionable insights.

I believe that quality work starts with quality writing. My goal is to make every report, guide, and process document not only compliant but understandable. I work with Excel, Teams, Word, PowerPoint, Dynamic, Veeva, and Veeva Vault in my daily line of work.

I also have a background in Lean Manufacturing, Six Sigma, TRS, SAP, and MES. Feel free to contact me at my email as I check it everyday.

The Pop in Your Job: What drives me in my work is knowing I am making a difference in patient care. I strive to ensure quality is upheld and to ensure proper and timely manufacturing so that all patients can receive the care they need. The medicine we create improves quality of life and even saves some as well.

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Sessions

How Can Organizations Design and Implement a CAPA System That Effectively Prevents Human Errors and Drives Continuous Quality Improvement?

3 | Preventive Café

Tuesday, March 24

11:00 am - 03:00 pm

Live in Everett

Less Details

  • What are the common root causes of human errors in regulated environments, and how can they be identified through CAPA investigations?
  • How can CAPA processes be structured to ensure timely detection, thorough investigation, and effective corrective actions?
  • What role does clear and consistent documentation play in preventing recurring issues and supporting compliance?
  • How can cross-functional collaboration enhance the effectiveness of CAPA systems and promote a culture of accountability?
  • What tools, technologies, or best practices can be leveraged to monitor CAPA effectiveness and drive continuous improvement?
Workshop

World Café Harvesting Session

Tuesday, March 24

03:30 pm - 04:00 pm

Live in Everett

Less Details

The moderators briefly summarize each World Café and present the key findings.

Presentation
Workshop

Company

Simtra BioPharma Solutions

As a premier, independently owned CDMO with over 65 years of sterile injectable manufacturing experience, Simtra BioPharma Solutions offers world-class cGMP sterile fill/finish, technical expertise, quality service, and a uniquely collaborative approach. Pharmaceutical and biotech companies partner with us when they face formulation challenges, clinical supply hurdles, surges in demand due to market fluctuations, or risk mitigation concerns. Our teams are driven to offer our clients tailored and versatile solutions to help them bring their products to market so they can get to the patients who need them. (Simtra is a tradename of Baxter Oncology GmbH and Simtra US LLC).
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Co-hosted with
Pharma MES USA 2026 is part of the Event Series. You can find more events here.
Date
March 23 – 24, 2026
Location
Encore Boston Harbor
1 Broadway
02149 Everett
Phone
+1(518)3102904
eMail
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