This webinar will provide an overview of current requirements
and offers keen insights into how to ensure your container and
package systems meet all regulatory guidelines
CLIFTON,
N.J., Sept. 18, 2024 /PRNewswire-PRWeb/ -- CS
Analytical Laboratory, the world's only FDA regulated contract
laboratory exclusively dedicated to providing regulatory solutions
and qualification testing services specifically for drug product
and medical device container systems is pleased to announce that in
partnership with Contract Laboratory they will host an educational
webinar titled "Container Qualification: Assembling a Comprehensive
Testing Strategy for Life Science Package Systems". The webinar, to
be hosted by CS Analytical Chief Scientific Officer Brandon Zurawlow, will take place on
Tuesday October 15th at 1:00pm EST. The webinar is free of charge and
attendees may register here:
https://outsource.contractlaboratory.com/container-qualification-assembling-a-comprehensive-testing-strategy-for-life-science-package-systems/
This webinar will provide an overview of
current requirements and offer keen insights into how to ensure
your container and package systems meet all regulatory
guidelines
"Over the past decade, the advances in the various types of
medical and drug product package systems, coupled with numerous
regulatory changes in qualification requirements has made the
package system approval process much more complex," noted
Brian Mulhall, CEO of CS Analytical.
"This webinar will provide an overview of current requirements and
offer keen insights into how to ensure your container and package
systems meet all regulatory guidelines."
Testing of pharmaceutical packaging components and systems such
as bottles and vials has been a regulatory expectation for decades.
However, over recent years, there has been a proliferation in the
types of materials used to create package components, novel package
designs, and unique products they are intended to hold.
Furthermore, drug-device combination products such as prefilled
syringes and injection systems, now common formats, introduce
unique considerations. As product-package systems, regulatory
requirements, and best practices evolve, navigating appropriate
test standards can be challenging.
Successful qualification requires reference to compendial
standards, such as those found in the USP, non-compendial
international standards, as well as custom studies and evaluations.
The unique product-package system and lifecycle must be considered
in assembling a suitable qualification strategy.
This webinar is intended to provide an overview of container and
package qualification across the product lifecycle. Topics will
include a review of relevant USP chapters as applicable to
different packing materials and components such as glass,
elastomers, plastic, and more, including a review of recently
revised and pending chapters. Critical evaluations referenced in
regulatory guidance and best practices, but not explicitly
prescribed in compendial chapters, such as distribution simulation
performed per ASTM / ISTA, will also be explored.
About CS Analytical Laboratory
The only FDA regulated, cGMP laboratory dedicated exclusively to
the complex world of drug and medical device container and package
qualification testing, the CS Analytical Team includes the world's
leading experts on all relevant USP and EP requirements and the
thought leaders and pioneers on CCI (container closure integrity –
CCI) testing. Offering a full suite of laboratory services to
include all USP, EP and JP procedures specific to glass, plastic
and elastomers as well as complete USP 1207 services that span
basic feasibility studies, component qualification programs and
advanced method development and validation for helium leak testing,
vacuum decay, high voltage and headspace analysis leak testing. CS
Analytical is the one source that can ensure your medical product
container and package system meets the strict and complex
regulatory requirements.
About Contract Laboratory
Contract Laboratory is an interactive web-based platform for
laboratory testing and outsourcing services. For the past 20 years,
the platform has facilitated numerous contract laboratory testing,
services, and business opportunities for government agencies, CROs,
start-ups, and even large multinational corporations.
Contract Laboratory is now a division of LabX Media Group and will
continue to expand services and offerings to meet the needs of the
laboratory testing and outsourcing industry.
Media Contact
Brian Mulhall, CS Analytical,
1-888-571-1207, engage@csanalytical.com,
https://csanalytical.com/
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SOURCE CS Analytical