Webinar On Best Practices for 510(k) Drafting and Submission: Dos and Don'ts
October 17, 2014 - Mississauga ON CACompliance Trainings
uttam@compliancetrainings.com
Phone:4169154458
From this webinar you will learn 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 session will greatly help you streamline your 510(k) preparation and submission process at your firm for maximum benefits in a least burdensome, effective manner. David 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 session 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 how to identify predicates: key factors 510(k) program: when the requirement is of 510(K) Regulatory requirements 510(k): requirements, contents and format Substantial equivalence: special considerations The task of addressing e-Copy and RTA policy requirements Some of the common mistakes for RTA policy requirements Applicable standards and guidance Common pitfalls and how to prevent them: dos and don’ts What to ensure while preparing for a 510(k) application Response to FDA’s request of additional information Resolving some of the different opinions and interpretations: dos and don’ts Speaker’s practical, actionable and sustainable solutions (PASS) Best Practices to achieve compliance and to stay compliant: dos and don’ts PASS-IT suggestions and recommendations 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