GMP for Phase I Investigational Drug Products 2018
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Website http://www.compliance4all.com/control/w_product/~product_id=501683LIVE?channel=ourglocal_Mar_2018_SE |
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Category Clinical Trials, Good Manufacturing Practices, compliance procedures, clinical compliance training, usp good documentation practices, Specialists courses
Deadline: March 21, 2018 | Date: March 22, 2018
Venue/Country: Online, U.S.A
Updated: 2018-01-30 16:19:18 (GMT+9)
Call For Papers - CFP
Overview:Phase I clinical trials are the first time that investigational new drugs are introduced into human subjects and, although it is very, very important for all drugs to be manufactured using GMPs, it is probably more important than at any other time during the lifecycle of the product, that a product be safe whenever humans are being exposed to it for the first time.Why should you Attend:FDAs guidance document "Good Manufacturing Practice for Phase I Investigational Drug Products" applies to correct GMP requirements to drug products made for the purpose of using an investigational drug product on human subjects for the first time, during conduct of Phase I clinical trials, which can begin if your IND is not put on clinical hold in 30 days after receipt by the FDA.Areas Covered in the Session:Statutory and Regulatory RequirementsPersonnel requirementsQC FunctionsFacility and Equipment RequirementsControl of Components and Containers and ClosuresManufacturing and Records Who Will Benefit:Senior Quality Managers, Quality VPsQuality Associates or SpecialistsRegulatory Management or Regulatory SpecialistsCompliance ProfessionalsSpeaker Profile:Stephanie Cooke is the President/CEO of Cooke Consulting, Inc. Stephanie uses her roughly 20 years of experience to provide global consulting services in various areas of Regulatory Affairs, Quality Assurance and validation for pharmaceutical, biological/biotech products, medical device, combination drug/device and nutraceutical firms.Event Fee: One Dial-in One Attendee Price: US$150.00Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: supportcompliance4All.com
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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