Conference about Combination Products: FDA's Final Rule for GMP Requirements
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Website http://bit.ly/GMP_Requirements |
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Category Combination Products in gmp, practices in gmp requirements, what is gmp combination products
Deadline: May 25, 2016 | Date: May 26, 2016
Venue/Country: Online Event, U.S.A
Updated: 2016-04-12 19:12:24 (GMT+9)
Call For Papers - CFP
Overview: What is a combination product? What are some examples of combination products? How are combination products assigned for review? Where can I find guidance for how master files can be used in the submission of information relevant to my combination product? Determine which Center will review my combination or non-combination product?Areas Covered in the Session:Introduction to Combination Products if you design, develop, produce, distribute and deploying a sustainable regulatory strategyDescription and explanation of FDA's proposed ruleRequirements for Single-Entity and Co-Packaged Combination ProductsIdentify requirements that apply to the constituent parts of a Combination Product before they are combined, or packaged togetherWhat current good manufacturing practice requirements apply to my combination product?Learn FDA's new terms and phrasesUnderstand how to address a Request for Designation for a combination or non-combination product and examples of "combo" productsResources and guidance to help define a proven regulatory strategyWho Will Benefit:All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overviewRegulatory AffairsClinical AffairsQuality and ComplianceMarketing & Sales DistributorsEngineering/Technical Services/OperationsConsultantsSpeaker Profile: David R. Dills , Regulatory Affairs & Compliance Consultant currently provides regulatory, compliance and quality consultative services for medical device and pharmaceutical/combination manufacturers, and also has an accomplished record with more than 24 years of experience with Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO.Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: supportcompliance4All.comhttp://www.compliance4all.com/Event Link : http://bit.ly/GMP_RequirementsLinkedIn Like us – https://www.linkedin.com/company/compliance4allTwitter Follow us – https://twitter.com/compliance4allFacebook Like us – https://www.facebook.com/Compliance4all
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