Webinar On Current GMP Requirements for Combination Products - Final Rule
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Category Human Relations
Deadline: September 04, 2014 | Date: September 04, 2014-September 05, 2014
Venue/Country: Mississauga, Canada
Updated: 2014-08-25 18:37:58 (GMT+9)
Call For Papers - CFP
As you know, medical diagnosis, technology, and treatment is very dynamic and is rapidly advancing. New discoveries are made that do not fit the "regulatory mold “and thus require new approaches to regulation. Combination products is one such area that has grown proportionally as technology advances creating in the need to rethink the processes for classification, design, quality assurance, and regulatory approval of such products. This challenges industry and the FDA to develop strategies for effectively working together to meet user and customer needs. As a professional, you are aware of the complexities of also combining the regulatory, business, and quality processes to make such products a reality.To deal with these complexities, the FDA published draft guidance for the application of GMP to combination products. The FDA determined that these requirements should be formalized in the Federal Register. The proposed rule was published in 2009 and the final rule was published on December 22, 2012 and was effective July 22, 2013. This webinar discusses this final rule and describes approaches to comply.At the end of this session, you will be ableTo understand where the combination products GMP rule applies.To learn & understand the differences between drugs, biologicals comments and after devices & their modes of actionsTo understand how they interact to produce combination productsTo learn and understand how to apply the regulation to your product and operationsTo gain additional perspective on how to apply quality principles to solve compliance problemsAreas Covered in the Session :Objectives & OverviewThe Draft Guidance vs. The Proposed Rule Vs. The Final RuleA quick review of the Pharmaceutical, Medical Device, and Biological GMP ContentsA Quick Overview and Analysis Of Industry Comments and the FDA ResponsesWho is in charge of your product CDER,CBER,CDRHScope, applicability and factors that impact the manufacturingQuality and compliance perspectives of the Final RuleFDA's discretionary enforcement of the Final RuleReviewing, Analyzing, & Understanding the Final Rule21 CFR Part 4, Subpart APractical Suggestions for complying with Combination Product cGMP SubpartsBeyond the regulation and its impactWho Will Benefit:QA / QC Managers and personnelRegulatory AffairsProduct ManagementSupervisors & Group LeadersProduction ManagementCompanies new to the FDA regulated industryPurchasingCompliance ManagementQuality Unit Vice Presidents & DirectorsVice presidents, Directors and Managers of OperationsConsultantsPrice Tags:LiveSingle Live : For One Participant$ 249Corporate Live : For Max. 10 Participants$ 899RecordingSingle REC : For One Participant - Unlimited Access for 6 Months$ 299Contact us atCompliance Trainings5939 Candlebrook Ct,Mississauga, ON L5V 2V6,CanadaCustomer Support : 416-915-4458Email : supportcompliancetrainings.com.
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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