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Webinar On Good Social Media Practices to Avoid FDA Actions

 
  October 01, 2015  
     
 


Compliance Trainings, Mississauga
2015-11-05


Description :

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

 
 
Organized by: Compliance Trainings
Invited Speakers: Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.com). 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 seven 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.
 
Deadline for Abstracts: 2015-11-05
 
Registration:

For more information about this event please visit

 

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1685

 

To register this webinar

https://compliancetrainings.com/siteengine/Login.aspx 

E-mail: suzzane.d@compliancetrainings.com
 
   
 
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