Understanding USP 661.1 and USP 661.2: Join Our Webinar
CS Analytical Hosts Educational Webinar on USP 661.1 and USP 661.2
The landscape of requirements surrounding USP 661 has dramatically evolved, presenting new complexities for the testing of plastic components utilized in container and package systems. The importance of comprehensively understanding these changes cannot be overstated, especially in light of the new mandates coming into effect on December 1, 2025.
Webinar Overview
Located in Clifton, N.J., CS Analytical Laboratory, the first and only FDA regulated contract laboratory focusing solely on regulatory and qualification testing services for drug products and medical device container systems, is preparing to host an informative webinar. This session will focus on the significant requirements of USP 661.1 and USP 661.2, which aim to ensure safety and compliance in product packaging.
Details of the Webinar
Scheduled for October 29, 2025, from 11:00 AM to 12:00 PM EST, the webinar will be led by Ronak Patel, the Chemistry Services Laboratory Manager, and will include insights from Brandon Zurawlow, the Chief Operations Officer. Participants will learn about both current and future testing requirements, essential for navigating the changes that are forthcoming.
The Importance of Compliance
Ronak Patel shared insights regarding the pressing need for companies to adapt to these changes, stating, "Understanding the intricacies of how these new regulations apply to your product line is crucial. Our goal for this webinar is to help businesses prepare for the impending compliance deadlines, especially since the existing 661 chapters will no longer suffice." This underscores the urgency for stakeholders in the industry to stay ahead of these requirements.
What to Expect from the Webinar
Attendees of the webinar will gain valuable knowledge about how to effectively plan for and implement testing that aligns with the new USP 661.1 and USP 661.2 guidelines. USP 661.1 focuses on characterizing materials of construction for packaging systems, while USP 661.2 targets the actual plastic components within those systems.
Strategizing for New Testing Requirements
With less than 45 days until the new requirements take effect, organizations should prioritize strategizing their approach to comply with these more rigorous testing mandates. This webinar is an excellent opportunity to arm themselves with crucial information that will help them transition smoothly to the updated standards.
About CS Analytical Laboratory
CS Analytical Laboratory stands out as the only FDA regulated, cGMP compliant lab that specializes in drug and medical device container/package qualification testing. The team comprises top-tier experts in all relevant USP and EP regulations, emphasizing integrity in testing methodologies. Their comprehensive service offerings include all procedures specific to glass, plastic, and elastomers.
Comprehensive Testing Services
In addition to standard testing, CS Analytical also offers advanced services such as helium leak testing, vacuum decay testing, high voltage testing, and headspace analysis. This range of tests ensures that your medical products consistently meet stringent regulatory standards.
Frequently Asked Questions
What is the focus of the CS Analytical webinar?
The webinar will focus on the new testing requirements under USP 661.1 and USP 661.2, effective December 1, 2025.
Who will be presenting the webinar?
Ronak Patel and Brandon Zurawlow will lead the session, sharing insights on the changes and compliance strategies.
Is there a cost to attend the webinar?
No, the webinar is free of charge for all participants.
How can I register for the webinar?
Registration can be done through the CS Analytical website, where you can sign up to secure your spot.
What are USP 661.1 and USP 661.2?
USP 661.1 pertains to the characterization of materials in packaging systems, while USP 661.2 relates to the testing of the actual plastic components used.
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