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Summary:A RAPS pre-approved webinar on the topic, “Developing and Maintaining Pre-marketing Master Regulatory Files” is being conductedon August 1 by GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider. This webinar earns 1.00 RAC credits towards a participant's RAC recertification upon full completion. The speaker of this 60-minute webinar will be Dr. John A. McLane, a regulatory and clinical services expert. ----------------------------------------------------------------------------------------------------------------- Description: When a medical device product has to show GXP procedure compliance, it has to submit many types of master regulatory files to regulatory authorities. It has to contain appropriate data and should havewell-organized source/support documentation. Each submission should have information from primary and secondary sources, which should be such that it can be tracked all the way from beginning till end both forward and backwards, right up to the source of the raw data, and should demonstrate all along that GXP procedures were followed all along. This calls for proper organization and tracking of regulatory files and their associated source documents. This seminar will present ways by which organizations can do this effectively. It will familiarize participants with relevant items that need to be tracked and their methods, so that pre-marketing master regulatory files are developed and maintained in such a way that they show compliance every step of the way. ----------------------------------------------------------------------------------------------------------------- When: October 1, 10:00 AM PDT 01:00 PM EDT ----------------------------------------------------------------------------------------------------------------- By whom:Dr. McLane has over 25 years of progressive experience in all phases of global development with both large and small pharmaceutical companies. His knowledge base has led to full development projects with over 50 clinical and medical device programs and to successful INDs, IDEs, NDAs and EMEA/CTA applications. Key strengths include the early development of clinical and regulatory strategies, risk management and identification, and negotiating with regulatory officials. Additional development activities include developing business rationale, teams, programs, and strategies for early clinical and combination product candidates in metabolic diseases, respiratory and oncology areas. He has also successfully completed in- and out-licensing reviews and negotiations including those for orphan indications and in vitro diagnostics. Dr. McLane has been leading recent regulatory and clinical services for clients in the various therapeutic areas at Clinquest. ----------------------------------------------------------------------------------------------------------------- For whom: The webinar will benefit o Regulatory affairs personnel o Quality assurance/control o Clinical operations o Project managers o Clinical Research Associates (CRA) o Clinical Trial Associates (CTA) o Medical monitors o Pharmacovigilance specialists o Site managers o Contract manufacturers o Nutraceutical manufacturers ---------------------------------------------------------------------------------------------------------------- Duration: 60 minutes ----------------------------------------------------------------------------------------------------------------- To enroll for this webinar, contact webinars@globalcompliancepanel.com Phone: 800-447-9407 AMAZINES.COM
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online Training, GXP requirementsTMF, DMF, Regulatory chronology, Regulatory master files, GMP documents,
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