Successful adoption of single-use technology in a biopharmaceutical process largely relies on confidence in the selection of materials. Understanding the regulatory and industry expectations are important to streamline the implementation and approval process.
This presentation will address the regulatory expectation for single-use manufacturing and demonstrate the key benefits of the Emprove®&nbsp;Program, including extractables data generated following the guidelines recommended by BioPhorum (BPOG) and adopting the USP &lt;665&gt; guidance. With a case study, a risk assessment process will be used to evaluate extractables and leachables requirements in a typical drug manufacturing process.
In this webinar, you will learn about:
<ul>
<li>Regulatory guidance for single-use manufacturing</li>
<li>Risk evaluation for single-use implementation</li>
</ul>

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<h2 class="webinar-subtitle">WEBINAR</h2>

Regulatory Considerations Including Extractables & Leachables for Single-Use Manufacturing

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This presentation will go through the regulatory expectation for single-use manufacturing and demonstrate the key benefits of the Emprove® Program including extractables data generated following the guidelines recommended by BioPhorum (BPOG) and adopting the USP <665> guidance.