Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

Join us for a webinar on November 10 for a discussion of the webinar.

Who will Benefit

  • Regulatory Affairs Director
  • Marketing Director
  • Quality Assurance Manager
  • Operations Managers
  • Complaint Department Manager
  • Human Resources Training Program Managers

Webinar Takeaway

  • Scope of Labeling and Claims 
  • Constitutional Protection of Commercial Free Speech 
  • Social Media Use
  • Dual Federal Legal Liability
  • Corporate Management’s Legal Responsibility and Liability

You will become familiar with these topics that are covered in the webinar:

  • Social Media Platforms as Labeling
  • False and Misleading Labeling
  • FDA and FTC Legal Declarations
  • Case Studies

Overview

FDA’s regulation of social media operates with a moving target. The scope of interest covers more than firms know or appreciate. What is OK or not OK with FDA remains vague, perhaps purposely so. FDA’s ambitious regulation has no boundaries. FDA reaches into areas that may cause disbelief and you think, “Really?” All social media platforms provide common ways to cross FDA’s legal boundaries for “misbranding” your product, whether knowingly or unknowingly and cause it to be illegal.  In the end, your firm’s executive management ends up with the legal responsibility for what happened. Pitfalls lurk in areas where you fail to take the initiative to check what is being said about your products and how you manage that dynamic of making claims. A failure to include an audit of social media platforms may end up surprising you with an unwelcomed letter from the FDA that explains how you are in violation of FDA law.  No one, especially your senior management, wants to be facing a problem with the FDA based on your failure to pre-emptively act on claims made in social media. You need an assertive defense.

FDA regulates how firms advertise and promote their products in social media and creates a regulatory risk of enforcement action when firm’s step over FDA’s somewhat mysterious advertising and promotion boundaries. What you or someone else says about your product, whether true, false or misleading, becomes a target for FDA’s legal hammer. FDA can levy fines, issue Warning Letters and even an injunction or prosecution end up creating a corporate crisis and confusing your customers or driving them away. 

Industries who can attend

This 60 minute online course is intended for professionals in the Pharmaceutical and Biopharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Casper Uldriks

Faculty Casper Uldriks

Former Associate Center Director, CDRH

Casper “Cap” Uldriks brings over 32 years of experience from the FDA. As a field investigator, he conducted import operations in the New England (Boston) District Office, which provides broad-based practical knowledge of FDA’s import program and procedures. As a senior manager in the Office of Compliance and as an associate center director for the Center of Devices and Radiological Health (CDRH), he served as the center’s expert on import and export operations and policy.

He managed the implementation of the FDA Export Reform and Enhancement Act of 1996 and development of intra-agency policy for imports, exports, and entry criteria for the FDA’s risk-based software screening program, known as PREDIDT. He routinely trained FDA staff and was featured as a public speaker on the statutory import and export requirements and how they operated for enforcement purposes. He is recognized as an engaging and energetic speaker. His comments are candid, straightforward, and of practical value.

Choose a Purchase Options


$279

Recorded Access - Unlimited viewing for 6 Months

For 1 Location Only

You'll have access to one log-in for an archived recording of the entire 60-minute webinar, including the Q&A period. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

$379

Training DVD

Multiple User Access

Within 48 hours delivered - Lifetime Access ,Audio recording of a webinar and reference manual delivered by download. Listen anytime on any compatible device.