Compliance Trainings, Online
2015-05-18
Description : FDA recently issued final 510(k) guidance, providing FDA’s policy on the 510(k) program. This webinar will provide great opportunities to get familiar with how to best prepare for a 510(k) for a successful submission and clearance: in particular, recent trends including Dos and Don’ts. Based on speaker’s recent experience, he will discuss best practices for adequately putting your 510(k) together for your successful submission to the FDA compliant with the FDA’s eCopy and RTA policy. This presentation will greatly help you streamline your 510(k) preparation and submission process at your firm for maximum benefits in a least burdensome, effective manner. In this presentation, 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 presentation is a must for regulatory professionals working in medical device industry including those who are interested in the topic. Areas Covered in the Session : Laws And Regulations Definitions Device Classification Predicates Recent FDA Final 510(k) Guidance When a 510(k) Is Required 510(k) Requirements Substantial Equivalence: Factors to Consider and Special Considerations Addressing e-Copy And RTA Policy Requirements Common Mistakes for eCopy and RTA Policy Requirements Common 510(k) Pitfalls: How to Prevent Them: Dos and Don’ts What to Ensure While Preparing for a 510(k) Application Responding to FDA’s Request of Additional Information. Resolving Different Opinions and Interpretations Best Practices for 510(k) Contents and Format PASS-IT Recommendations: Dos and Don’ts Who Will Benefit: Medical Device Quality and Compliance Professionals Pharmaceutical Compliance Professionals Quality Regulatory Affairs CEOs VPs Attorneys Clinical Affairs Research & Development Consultants Contractors/Subcontractors Anyone Interested in the 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
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