Implementing Best Practices for FDA 510(k) Planning, Preparation, Submission and Clearance

Event Information
Product Format
Prerecorded Event
Presenter(s)
Dr. David Lim, Ph.D., RAC, ASQ-CQA
Conference Date
Wed, Feb 15, 2017
Length
60 minutes
Product Description

Best Practices in Drafting an FDA 510(k): Preparation, Submission, Clearance, and Complying with Refuse to Accept Policy

With this session by expert speaker, Dr. David Lim, Ph.D., RAC, ASQ-CQA, you will get familiar with the “Best Practices” to draft an FDA 510(k) including the Dos and Don’ts to it. The session will discuss the best practices to adequately put your 510(k) together for successful submission to the FDA, complying with the FDA’s eCopy and Refuse to Accept (RTA) policy.

The session will help you streamline the 510(k) preparation and submission processes at your firm for maximum benefits in an effective and least burdensome manner. Dr. Lim will share some inside tips based on his learnings and his experience including his analysis of 510(k)s, which has been recently cleared.

It is a must attend session for regulatory professionals, who are working in medical device industry, and those who are interested in the topic. The session will discuss about premarket notification (510(k)) and regulatory requirements. You will also learn how to put together a 510(k) package for submission and clearance from the FDA.

Session Highlights

  • Statute(s) and Regulations
  • Definitions
  • 510(k) Regulatory Requirements
  • Common Pitfalls and How to Prevent Them: Dos and Don’ts
  • Preparing for a 510(k) Application
  • Best Practices for 510(k) Submission and Clearance: Dos and Don’ts
  • PASS-IT Suggestions and Recommendations

Who Should Attend

  • Medical Device Quality and Compliance Professionals
  • Pharmaceutical Compliance Professionals
  • Quality
  • Regulatory Affairs
  • CEOs
  • VPs
  • Attorneys
  • Clinical Affairs
  • R&D
  • Consultants
  • Contractors/Subcontractors
  • Anyone Interested in Dealing with 510(k) Matters

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

Order Below or Call 1-866-458-2965 Today

You can also order through:
Phone

1-866-458-2965

Fax

1-919-287-2643

About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert


Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.


Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
More Events By The Speaker

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