Compliance Trainings, Online
2015-02-04
Description : This webinar will provide an opportunity to get familiar with an FDA's process to communicate with the industry early in the process for sustainable 510(k) preparation and submission. This webinar is intended to discuss how to put together a pre-submission (Q-submission) to obtain FDA feedback on your proposed questions, which will be helpful and useful for your device design, preclinical and clinical study plan and design, if applicable. The speaker will discuss contents and format for a Q-submission and 510(k)compliant with the FDA's eCopy and RTA policy, helping you streamline your dialogue with the FDA for maximum benefits while preparing for a 510(k) submission in a least burdensome, effective manner. In this webinar, the speaker will share his PASS-IT solutions based on what he has learned from his own experience including his recent analysis of various different types of 510(k)s that have been recently cleared. This webinar is a must for regulatory professionals working in medical device industry including those who are interested in the topic. Areas Covered in the Session : Statute(s) And Regulations Definitions Device Classification And Predicates 510(k) Program When 510(k)s Are Required Applicable Regulatory Requirements: Biocompatibility, Software, Risk Management, etc. Pre-Submission (Q-Submission) for a 510(k): Requirements, Contents and Format Substantial Equivalence: Factors to Consider and Special Considerations Addressing e-Copy And RTA Policy Requirements Applicable Standards and Guidance 510(k) Contents And Format Common Pitfalls and How to Prevent Them What to Ensure While Preparing Your Q-Submission and a 510(k) Application Responding to FDA's Request of Additional Information. Resolving Different Opinions and Interpretations Best Practices for a Q-submission Best Practices for a 510(k) Preparation, Submission and Clearance Speaker's Practical, Actionable and Sustainable Solutions Conclusions Who Will Benefit: Regulatory Affairs Research & Development Quality Assurance Quality Control Quality System Management CROs Consultants Contractors/Subcontractors Senior management Anyone interested in 510(k) matters Price tags: Live Single Live : For One Participant $ 249 Corporate Live : For Max. 10 Participants $ 899 Recording Single REC : For One Participant - Unlimited Access for 6 Months $ 299 For more information and enquiries contact us at Compliance Trainings 5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada Customer Support : #416-915-4458 Email : support@compliancetrainings.com https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1358
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