2018: FDA's New Inspection Policy and Strategic Regulatory Updates

Product Id : FDA117
Instructor : Carolyn Troiano
May 03, 2018 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes

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Learn FDA Compliance Guidelines, Dos and Don’ts to Prepare for Risk-Based Inspections

In FDA-regulated industries, it is imperative that firms should be well aware of and understand the laws and regulations governing FDA-regulated medical products (e.g., food, drugs, biologics, cosmetics, and medical devices including in vitro diagnostics). In particular, it is important to recognize policy changes and risk-based, strategic regulatory and compliance approaches (best practices) under the new administration.

In this sessions, expert speaker Carolyn Troiano, will discuss FDA’s policy changes, risk-based regulatory and compliance approaches under the new administration for 2018 and beyond. Carolyn will help you better prepare for risk-based FDA inspection and management, in a proactive and effective manner. Carolyn will share her actionable tips and advice in view of recent FDA policy changes and enforcement actions. She will help you improve your awareness and knowledge of FDA enforcement and inspection policy and risk-based approaches under the new administration.

Carolyn will discuss practical, actionable, and sustainable guidance on how to prepare for a risk-based FDA inspection and how to manage the FDA inspection process, including the dos and don’ts before, during, and after the inspection. With this session, you will become familiar with the lessons learnt from the FDA enforcement and inspection practices. Carolyn will also share her recommendations/suggestions for the dos and don’ts of PASS-IT.

Learning Objectives:

  • Preparing for 2018: FDA Inspection Policy and Best GMP Practices
  • 2018 and Beyond: FDA’s New Policy and Risk-Based Strategic Regulatory Updates Under New Administration
  • What to Expect from Changes in FDA Policy and Inspection Operation in 2018

Session Highlights:

  • Laws and regulations
  • New administration
  • FDA policy
  • FDA enforcement
  • Risk-based approaches
  • Industry misconceptions
  • FDA inspection preparation and management
  • Important awareness to improve
  • Communication with the FDA
  • Employee training
  • Actual case studies
  • Speaker’s PASS-IT suggestions/recommendations and dos and don’ts
  • Conclusion

Who Will Benefits:

  • CEOs
  • VPs
  • Compliance officers
  • Attorneys
  • Regulatory affairs personnel
  • Clinical affairs personnel
  • Quality assurance personnel
  • R&D personnel
  • Contractors/subcontractors
  • Consultants
  • Anyone interested in the FDA regulatory pathways for new drugs and generics
Speaker Profile:

Carolyn Troiano has vast experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries, in which she has worked as a consultant for over 30 years. She has provided services to many large pharmaceutical and tobacco companies throughout the US and Europe. As part of her services, she has helped develop and execute compliance strategies and programs.

Carolyn also has experience in supply chain security and compliance, which includes technologies and procedures for improving the protection of companies’ brand integrity. At present, she is active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI).


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