FLASH DRIVE

Description

In FDA-regulated industry, it is imperative that firms should be well aware of and understand what laws and regulations apply for FDA-regulated medical and other products like food, drugs, biologics, cosmetics and medical devices including in vitro diagnostics. The FDA conducts inspection to enforce these rules and regulations.

This webinar is intended to discuss FDA inspection practices in 2018 and to help industry better prepare for and manage an FDA inspection in a proactive and effective manner.  The speaker will share his actionable tips and advice in view of recent FDA policy changes.

The speaker will also discuss practical, actionable, and sustainable guidance on how to prepare for a sustainable FDA inspection and how to manage the FDA inspection process including Dos and Don’ts before, during and after the inspection.  This presentation will provide great opportunities to become familiar with what lessons we learn from FDA enforcement and inspection practices.

The speaker will share his PASS-IT recommendation/suggestions – dos and don’ts.

Area Covered In The Session:

  • Laws and Regulations
  • FDA Policy
  • FDA Inspection Manuals
  • Most Common Deficiencies
  • Actionable Inspection Preparation and Management
  • How to Communicate with EQ Skills
  • Employee Training
  • Actual Case Studies
  • Speaker’s PASS-IT Suggestions/Recommendations-Dos and Don’ts
  • Conclusion

Learning Objectives:

At the conclusion of the session,

  • Participants will be able to improve their awareness and knowledge of FDA enforcement and inspection practices in preparation for 2018.
  • Participants will be able to understand FDA Inspection Manuals and most common pitfalls practiced while complying with FDA.
  • Participants will know how to prepare for a sustainable FDA inspection and how to manage the FDA inspection process including Dos and Don’ts.
  • With the help of actual case studies, participants  will be able to identify and manage different FDA issues practically.

Target Audiences:

  • 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.

About Our Speaker:

Dr. David Lim, Ph.D., RAC, ASQ-CQA, is President and Principal of Regulatory Doctor Consulting Firm (www.RegulatoryDoctor.us).  Dr. Lim is a leading industry speaker and frequently presents global regulatory and quality compliance topics in various forums and meetings. He also provides consulting services to various companies, venture capital firms, consultants and consulting firms.

Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance matters.  Dr. Lim has also advised many firms including, but not limited to risk management firms, venture capital firms, asset management firms, and fund managers to make right investment decisions in view of FDA regulatory and compliance matters.