Tuesday, November 7, 2023

Considerations for Compliant Software Configuration

Software is integrated into every point of our workflows and laboratory software that supports your system of regulatory compliance should offer modern tools to assist you. Learn how Thermo ScientificTM ChromeleonTM Chromatography Data System (CDS) can help you streamline your results reporting and review cycles with automatic and configurable context capture tools, granular privilege settings, and flexible reporting options that utilize familiar software skills. 

Join us for a review of: 

• Chromeleon CDS software configuration of settings, policies and privileges that support ALCOA principles. 
• How to collect or require comments at any software level, from changes to a processing method down to placing individual comments on individual peak integrations, and then add them to a report. 
• Report editing and formatting tips and tricks including adding audit trails to support single-location review.
  

Presenters: Zoe Julian and Crystal Welch
Thermo Fisher Scientific
11:00am-12:00 pm EST

Wednesday, November 8, 2023

New Paradigms in Immunohistochemistry Quality Assurance

Weighing very small sample amounts is a decisive step in many laboratory applications and respective weighing results are required to be as accurate and reliable as possible. At the same time, effects deriving from the laboratory environment or the sample itself can negatively influence the weighing process. Additionally, proper cleaning of a laboratory balance is necessary to maintain the best weighing performance and avoid sample cross-contamination. 

In this webinar, you will learn how to manage and compensate for these effects and perform appropriately using the new Sartorius Cubis®II Ultra-High Resolution Balances. 

Key learning objectives: 

• Discover how environmental effects like place of installation, air drafts, and temperature changes can negatively influence your weighing results 
• Learn how to recognize and avoid effects deriving from samples (e.g. magnetism, electrostatics, or bad acclimatization) 
• Explore how to perform proper cleaning of your lab balance during your daily routine or after spillage of samples 
• Find out how built-in solutions can intuitively help to overcome problems
  

Presenter: Lars Wallbaum
Sartorius
11:00am-12:00 pm EST

New Paradigms in Immunohistochemistry Quality Assurance

A regulatory paradigm shift is on the horizon for immunohistochemistry (IHC) quality assurance (QA), driven by data revealing alarmingly high rates of inter-laboratory discrepancies in IHC—anomalies far surpassing those in serum or plasma immunoassays. One major culprit is the variability arising from IHC slide staining. The July 2023 editorial in the Archives of Pathology & Laboratory Medicine underscores a clarion call: an overhaul of IHC QA regulations, urging the adaptation of regulatory practices from clinical immunoassay to IHC. Such an overhaul is not without its challenges, necessitating clinical IHC laboratories to undergo significant adaptation. 

In this seminar, our speakers will take a deeper dive into the heart of this issue, and highlight IHC quality assurance tools on the horizon: notably, the first IHC NIST reference standard and system for IHC calibration and statistical process control (Levey-Jennings). In essence, 2024 promises the debut of tried-and-tested QA protocols from clinical pathology into the realm of immunohistochemistry. 

Major topics to be covered: 

• The disparities in laboratory QA regulations between IHC and immunoassays. 
• Published data describing the consequences for patient management, especially for precision medicine therapeutics linked to IHC companion diagnostic tests. 
• How NIST SRM 1934 has become a universal IHC reference standard, addressing the need for IHC measurement traceability. 
• The first technology for measuring the lower limit of detection and dynamic range for immunohistochemistry assays and published examples—how it works and published examples. 
• The first systems for IHC statistical process controls (Levey-Jennings graphing) and practical deployment in lab workflows.
  

Presenters: Michael Grunkin and Steve Bogen
Visiopharm A/S; Boston Cell Standards Inc.
12:30-1:30 pm EST