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.
TORONTO, March 20, 2018 (Newswire.com) - 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.
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Contact:
Nima Rajan
Tel: +1 (416) 977-6555 ext 352
Email: [email protected]
Source: Xtalks
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Tags: analytical development, biopharmacutical manufacturing, extractables, formulation, leachables, medical device, Nitto Avecia Pharma Services, pharmaceutical, Xtalks
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