Good Social Media Practices to Avoid FDA Actions

This seminar is intended to help you adequately implement good social medical practices to avoid FDA enforcement actions for potential misbranding of your drug or device products.

The U.S. Food and Drug Administration (FDA) reviewed the firm’s sponsored link on the Google as part of the FDA’s routine monitoring and surveillance program by the Office of Prescription Drug Promotion (OPDP). It is imperative that firms ensure their compliance to the applicable laws and regulations when they provide drug or device information to the public through social media.

In this presentation, the speaker will discuss what to say or not to say including how to implement your good social medical practices while ensuring your compliance by avoiding potential FDA enforcement actions.

The speaker will present how to implement good social media practices in a CAC-SI manner (CAC-SI refers to current, accurate and complete/comprehensive in a systematic, integrated manner).

Through this 60-min presentation, you will have opportunities to bring great value and benefits to your firm’s implementation of good social media practices in an efficient and effective manner.

Areas Covered in the Session :
Applicable Statute(s) and Regulations
Definitions
Regulatory Requirements
FDA’s Monitoring and Surveillance Program
FDA Social Media Guidance Documents
Implementing Good Social Medical Practices
FDA’s Untitled Letter Analysis
Common Avoidable Mistakes
How to Prevent Common Mistakes
How to Avoid FDA’s Actions
PASS-IT Guides
Conclusion

Who Will Benefit:
R&D Scientists, Managers, Directors, and VPs
Regulatory Affairs and Compliance Professionals
Clinical Affairs Professionals
Quality Professionals
Consultants
Legal and Compliance Officers
Marketing Professionals
Senior Management
Anyone Interested in the Subject

Dr. David Lim

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.

membership
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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance