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

Discussion on US FDA’s Strategic Priorities

Since 2009, there have been lots of changes being implemented at the FDA.  Understanding FDA’s strategic priorities for 2014 and beyond can help prioritize business goals and objectives concerning regulatory plan/strategy, product approvals and clearances and FDA registration and listing.

Based on new laws, statutes and new regulations, US FDA is implementing the statutory requirements.  It is imperative that the healthcare industry understand what regulatory requirements may be relevant and applicable to firms affected.

Join Dr. David Lim, Ph.D., RAC, ASQ-CQA in this audio session to 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.  

In this 60 minute session, David will share US FDA’s strategic priorities – 2014 and beyond.

Areas To Be Covered in this Session:

  • New Laws and Amendments to the Statute(s)
  • New Regulations
  • Common Misconception about Laws, Regulations, and New FDA Guidance Documents
  • FDA Implementation of the FDASIA 2012
  • FDA Implementation of the Compounding Quality Act
  • Compounding Quality Act Requirements
  • FDA Registration and Listing
  • FDA Implementation of the Unique Device Identification System
  • FDA Implementation of the Global UDI Database (GUDID)
  • GUDID Requirements: Meaning to the Various Stakeholders
  • FDA’s Regulatory Science Program
  • Changes in CDRH/FDA
  • FDA and ISO 13485 Pilot Audit Program
  • Potential Changes in FDA Inspection Due to FDASIA 2012
  • Current Good Manufacturing Practices for Drugs and Devices
  • FDA’s Increased Enforcements: The Areas to Pay Special Attention to
  • Speaker’s PASS-IT Suggestions/Recommendations
  • Conclusion

Who should attend

  • CEOs
  • VPs
  • Compliance Officers
  • Attorneys
  • Regulatory Affairs
  • Clinical Affairs
  • Quality Assurance
  • R&D
  • Consultants
  • Contractors/Subcontractors
  • Anyone Interested in the US FDA’s Strategic Priorities

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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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