A Systematic Approach to Extractables and Leachables: A Review of Guidance From the Industry, New Webinar Hosted by Xtalks

Session to provide best practices, insights, and sample case studies for extractables and leachables studies in accordance with guidelines for the bio/pharmaceutical industry.

Xtalks Life Science Webinars

In a live broadcast upcoming on Tuesday, April 3, 2018 at 2 p.m. EDT, subject-matter expert Aryo Nikopour, Senior Vice President of Scientific and Technical Services at Nitto Avecia Pharma Services will review best practices (including case studies) and provide a thorough systematic approach to extractables and leachables in accordance with PQRI (Product Quality Research Institute), BPOG (BioPhorum Operations Group) and/or USP General Chapters <1663> and <1664> for the various phases of extractables and leachables including:

·         Controlled extraction studies

·         Model extraction studies

·         Leachables method development and validation studies

·         Leachables studies in support of stability

This webinar is an excellent opportunity for individuals involved in analytical development, formulation development, and manufacturing to expand their knowledge and develop an optimal approach for extractables and leachables in support of single-use systems and containers/closures including, but not limited to:

·         Injectable products

·         IV bags

·         Medical devices

·         Ophthalmic

·         LDPE ampoules

·         PVC blister packs

·         Inhalation products

·         Nasal products

Register for this free webinar today and help eliminate possible risks of introducing foreign materials to your drug development process and expedite time to market. 

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical and biotech companies, private and academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends, and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com

For information about hosting a webinar visit http://xtalks.com/sponsorship.ashx

Contact:

Nima Rajan

Tel: +1 (416) 977-6555 ext 352

Email: nrajan@xtalks.com

Source: Xtalks

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Categories: Pharmaceuticals and Biotech, Manufacturing, Packaging, Chemicals

Tags: analytical development, biopharmacutical manufacturing, extractables, formulation, leachables, medical device, Nitto Avecia Pharma Services, pharmaceutical, Xtalks


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Xtalks is a leading provider of educational webinars to the global life science, food and medical device community.