In Person Seminar for 510(k) Drafting in Washington, DC
How to Format Succinct and Comprehensive 510ks
Hotel (To be announced shortly)
Nov 12, 2015 – Nov. 13, 2015
- $999 (Single Attendee) Until October 12, 2015; $1299 after October 13, 2015
About the In-Person 510(k) Drafting Seminar
It is imperative that medical device firms quickly recognize evolving regulatory requirements in the US. In particular, it is important to adequately understand the 510(k) process so that the review process can be facilitated in a proactive, effective, and streamlined manner.
This seminar will discuss the US FDA 510(k) submissions in great detail. The speaker will walk you through how to format a succinct and comprehensive 510(k) while addressing all applicable, regulatory and essential requirements.
This seminar will provide great opportunities to learn how to put together technical documentation for 510(k)s.
Why to Attend the In Person 510(k) Drafting Seminar
A premarket notification [510(k)] is the most common pathway to market for medical devices in the US. The 510(k) premarket submission is made to demonstrate that the subject device (to be marketed) is substantially equivalent to a legally marketed device (predicate device) as described in 21 CFR 807.92(a)(3).
Over the years, there have been changes to the FDA’s 510(k) program and requirements including FDA’s issuances of key guidance documents (e-Copy, RTA policy and final 510(k) guidance).
In order to successfully obtain marketing clearances [510(k)s], it is important to adequately put your 510(k) together for your successful submission to the FDA, compliant with the FDA’s eCopy and RTA policy. This seminar will greatly help you streamline your 510(k) preparation and submission process at your firm for maximum benefits in a least burdensome, effective manner. 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 session is a must for regulatory professionals working in medical device industry including those who are interested in the topic.
This seminar will help you save your firm’s significant efforts and resources, potentially saving millions of dollars by learning actionable approaches with improved awareness and familiarity.
Who Will Benefit
This seminar will be valuable for anyone in the FDA-regulated industry including, but not limited to, medical device, drugs, biologics, in vitro diagnostic devices, combination products or companion diagnostics. It is particularly useful for those who are engaged in the design and development of medical devices, combinations products (e.g., drug and devices, biologics and devices), and in vitro diagnostic devices including companion medical products. This seminar is a must for those who are directly or indirectly involved in handling regulatory submissions, 510(k)s to the FDA.
- Regulatory affairs (associates, specialists, managers, and directors)
- Clinical affairs (associates, specialists, coordinators, managers, directors and VPs)
- Quality assurance, quality control, and quality systems (associates, specialists, engineers, managers, directors and VPs)
- Research and development (associates, scientists, managers, directors and VPs)
- Product and development (associates, scientists, managers, directors and VPs)
- Marketing (associates, specialists, managers, directors and VPs)
- Contract manufacturing organization (associates, scientists, managers, directors and VPs)
- Contract research organization (associates, scientists, managers, directors and VPs)
- Senior and executive management (VPs, SVPs, Presidents, and CEOs)
- Contractors and subcontractors
- Compliance professionals
- Legal counsel
Day One: November 12, 2015
Morning (09:00 – 12:00 Noon)
- Statutes and Regulations
- 510(k) Program and Changes
- 510(k) Regulatory Requirements
Afternoon (01:00 – 04:00 PM)
- FDA Guidance Documents & Standards
- How to Improve 510(k) Submission Quality
- Quality System Regulations
Day Two: November 13, 2015
Morning (09:00 – 12:00 N0on)
- How to Best Format Succinct and Comprehensive 510(k)s
- Submission Reviews Based on Actual Cases/Examples
- Practical, Hands on Skills
About the Speaker
Dr. Lim is President and Principal of Regulatory Doctor (Regulatory Doctor), providing global and FDA consulting services in various areas of regulatory affairs, quality, clinical affairs and regulatory compliance matters. As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) and PMA/HDE templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.
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510(k) In Person Seminar: $999