US FDA’s Strategic and Regulatory Science Priorities – 2016 and Beyond

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
60 minutes
Product Description

Prioritize Your Business Processes in Strategic Response to the Evolving Regulatory Environments by Understanding FDA’s Strategic Priorities for 2016 And Beyond.

This presentation is intended to discuss US FDA’s Strategic Priorities – 2016 and Beyond. 

Since 2009, there have been a lot of changes being implemented at the FDA. Understanding FDA’s strategic priorities for 2016 and beyond can help firms better understand and use the services or regulatory processes what the FDA offers.

It is believed that once the firms are familiar with FDA’s regulatory environment and strategic priorities, the firms can prioritize business goals and objectives in view of evolving regulatory science, regulatory plan/strategy including regulatory requirements for product approvals or clearances.

Based on new laws, statutes and new regulations, the FDA’s strategic priorities have evolved in implementing the statutory and regulatory requirements. It is imperative that the healthcare industry should understand FDA’s strategic priorities for the year 2016 and beyond so that industry can use the relevant and applicable information to better prioritize business processes in strategic response to the evolving regulatory environments.

This presentation by our expert speaker Dr. David Lim, Ph.D., RAC, ASQ-CQA will provide great opportunities to improve industry’s awareness for FDA’s strategic priorities for 2016 and beyond. Dr. Lim will share FDA’s various programs and strategic priorities for 2016 and beyond.

Why Should You Attend:

In this webinar, you will learn and understand the applicable regulatory requirements so that implementation of necessary regulatory requirements, if applicable, can be planned early and carried out in an effective and sustainable manner.

Session Highlights:

  • Governing Laws and Regulations Including New and Amendments
  • Common Misconception about Laws, Regulations, and New FDA Guidance Documents
  • FDA Programs for Food, Drugs, Biologics and Medical Devices
  • FDA Accomplishments
  • Significant Items from US Senate to the FDA
  • FDA User Fees
  • FDA Priority Areas
  • Regulatory Science Priorities for Devices
  • FDA Implementation of Compounding Quality Act Requirements, UDI System and GUDID
  • FDA Information Technology: Processes and Developments
  • FDA Goals and Objectives for 2016 and Beyond

You will also get answers to the following tough questions:

  • During FDA inspection, can a firm discuss an objection or action regarding observations made by an FDA representative?
  • What are the FDA's recent inspection trends?

Who should attend?

  • Professionals in healthcare industry: drugs, biologics, medical devices/IVDs, combination products, etc.
  • Compliance Officers
  • Regulatory Affairs
  • Clinical Affairs
  • Quality Assurance
  • Laboratory Personnel
  • IT Professionals
  • R&D
  • Consultants
  • Contractors/Subcontractors
  • Other professionals interested in this topic

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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 ( 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
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