United States
January 27, 2016
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If you use pharmaceutical Contract Manufacturing Organizations (CMOs), your company has ultimate responsibility and accountability for product quality, safety, and efficacy; as well as cGMP compliance. Furthermore, FDA has stated that organizations using CMOs will be held accountable for CMO compliance to cGMPs, as well as CMO adherence to the contracting firm’s regulatory commitments. Therefore, issues identified at your CMO may result in FDA 483s and/or Warning Letters issued to your company. In other words, you cannot just outsource operations and forget about it. You must select the proper CMOs and actively manage the operations performed on your behalf. At the end of the day, your organization’s ability to provide proper quality oversight of CMOs is the key to assuring product safety and your company’s compliance profile.


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