What We Should Expect from Changes in FDA Policy and Inspection Operation in 2018

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
Conference Date
Thu, Feb 15, 2018
60 minutes
Product Description

Prepare for 2018: Comply with Recent Changes in FDA Policy and Inspection/Enforcement Operation

In FDA-regulated industries, it is imperative that firms be well aware of and understand what policy changes have occurred that will impact them in 2018. In particular, it is critical to learn what policy changes have been implemented for the FDA inspection operation already in force since October 2017. Recent policy changes are widely applicable to FDA-regulated medical products, such as food, drugs, biologics, cosmetics and medical devices including in vitro diagnostics.

Join this session, where regulatory and compliance expert Dr. David Lim, Ph.D., RAC, ASQ-CQA, will discuss the recent changes in FDA policy and the FDA inspection/enforcement operation for 2018. This session will help you better prepare for and manage an FDA-inspection in a proactive and effective manner. David will share his actionable tips and advice in view of recent FDA policy changes.

David will cover the changes to FDA’s new policy and inspection operation practices in 2018. He will discuss how to prepare for a sustainable FDA inspection and will help you be prepared for FDA enforcement and inspection. You will learn the dos and don’ts of the before, during and after aspects on managing the FDA inspection process. With this session, you will improve your awareness and knowledge of FDA enforcement and inspection practices in 2018. David will also share the dos and don’ts of his PASS-IT recommendation and suggestions.

Session Highlights

  • Laws and regulations
  • 2018 policy changes
  • Changes in FDA inspection policy
  • Changes in FDA inspection operation
  • Trends in deficiencies and how to avoid them
  • Actionable strategies for inspection preparation and management
  • Communication with EQ skills
  • Employee training
  • Actual case studies
  • Dos and don’ts on PASS-IT suggestions and 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 FDA regulatory pathways for new drugs and generics

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

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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 (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

Creighton University Health Sciences Continuing Education designates this activity for 1.0 contact hour(s) for nurses. Nurses should claim only the credit commensurate with the extent of their participation in the activity.
Nurses licensed in Iowa and California: This activity was planned and developed in accordance with the continuing education standards of the American Nurses Credentialing Center (ANCC). The Iowa Board of Nursing and the California Board of Nursing will honor ANCC continuing education credits for face-to-face programs held outside Iowa and California, or for ANCC-approved online recorded courses taken in a self-study format.
In support of improving patient care, this activity has been planned and implemented by Creighton University Health Sciences Continuing Education and Audio Educator. Creighton University Health Sciences Continuing Education (HSCE) is jointly accredited by the Accreditation Council for Continuing Medical Education ( ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
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