ELPRO hosts Clinical Supply workshop at IQPC Boston event September 27th19.Sep.2016
ELPRO will be teaching a workshop on «Preparing your Clinical Supply Operations for the Volume of CRT and Speciality Biologics» Septemer 27th at the IQPC GDP Cold Chain Global Forum in Boston.
This timely workshop will review the new chapter in United States Pharmacopeia (USP) 1079 guideline on Storage and Transportation of Investigational Drug Products (IDPs), released earlier this year. As regulatory and industry standards continue to increase, pharma manufacturers and their supply chain partners need to comply with stricter criteria for proving effectiveness and safety of IDPs.
Workshop discussion topics include how to better control processes at clinical sites, strategies for using stability data for clinical shipments and using multi-level temperature monitoring to ultimately reduce excursions.
Logistics and QA professionals will attend to discuss how to gain better supply chain visibility, evaluating performance of shipping lanes implement quality check points at clinical sites.
The USP Prospectus states “the pre-commercial nature of IDPs means the manufacturing ingredients, including active pharmaceutical ingredients (APIs), excipients, the clinical trial dosage, and any associated stability and packaging components may not be as defined as they would for a final approved finished product.»
ELPRO workshop facilitators will be Cyril Winkler, Cold Chain Product Manager and Micalyn Harris, VP Sales North America.
The IQPC GDP Global Forum week is a major event for temperature control professionals with 32 countries represented. Additional conference speakers include the FDA, United States Pharmacopeia, Baxter, Genentech, Astellas, Lilly, Bristol Myers Squibb, among others.
ELPRO has discounted passes available. Please contact us to enquire usa[at]elpro.com