Understanding FDA Regulations Governing GCP, GLP and GMP for Drugs, Biologics and Medical Devices
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Category Biotechnology , Medical Device , Pharmaceutical
Deadline: March 16, 2016 | Date: March 16, 2016
Venue/Country: Online, U.S.A
Updated: 2016-02-09 19:20:33 (GMT+9)
Call For Papers - CFP
DESCRIPTIONIt is important for the FDA-regulated industry to better understand applicable FDA regulations governing Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP) for drugs, biologics and medical devices including in vitro diagnostics (IVDs).This webinar is intended to help the FDA-regulated industry get better familiar with the GLP, GCP and cGMP requirements from regulatory perspectives.Understanding and adequately implementing the regulatory requirements under GLP, GCP and cGMP regulations are critical to firm’s decision-making process, helping to save an enormous amount of resources.In this presentation, the speaker will discuss FDA regulations including key provisions and requirements governing GCP, GLP and GMP applicable to drugs, biologics and medical devices including IVDs.Areas To Be Covered in this Webinar:Laws and RegulationsDefinitionsGood Laboratory Practice (GLP): Regulation and Important RequirementsGood Clinical Practice (GCP): Regulation and Important RequirementsRegulations for Current Good Manufacturing Practice (CGMP) for Food, Drugs, Biologics and Medical DevicesFDA Guidance(s) and Standard(s)Best Practices When Implementing GLP, GCP and GMP: Dos and Don’tsSpeaker’s PASS-IT RecommendationsWho will benefit:Professionals in healthcare industry: drugs, biologics, medical devices/IVDs, combination products, etc.Compliance OfficersRegulatory AffairsClinical AffairsQuality AssuranceLaboratory PersonnelIT ProfessionalsR&DConsultantsContractors/SubcontractorsOther professionals interested in this topicWebinar Includes:Q/A Session with the Expert to ask your questionCopy of PowerPoint slides (PDF print only)60 Minutes Live PresentationCertificate of Attendance
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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