Medical Device Marketing and Promotion Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar will provide clarification on which medical device facility or establishment must register and list, how to register and list, and how to coordinate the payment process to accomplish the actual registration or device listing.

This webinar on tobacco regulations will discuss FDA regulatory requirements for tobacco products. It will prepare you for FDA’s Deeming Regulations for cigars, pipe tobacco, electronic cigarettes, dissolvable tobacco and other novel tobacco products.

This webinar will discuss in detail the FDA guidance on medical device recalls including its role, expectations and enforcement policy. It will cover key topics on medical device recall including recall classification, firm’s responsibilities for a recall, recall communication, recall strategy, FDA expectations and much more.

This 510(k) and risk management webinar will discuss FDA expectations for information supplied in the 510(k) application and how to best demonstrate that product is safe.

This webinar will discuss the FDA guidelines for handling unsolicited requests about off-label information. It will provide attendees a list of dos and don’ts related to social media techniques in off-label promotion.

This webinar will provide tips and techniques on how to research and identify appropriate predicate devices for a 510(k) application.

This webinar explains the excise tax on medical device manufactures that went into effect on January 1, 2013, including the devices it covers and the effective selling price for tax purposes.

The Webinar will discuss the structure and level of detail required in filing a 510(k) when a medical device is software or contains software.

This webinar will discuss best practices for premarket notification [510(k)] preparation and submission compliant with FDA's eCopy and Refuse to Accept (RTA) Policy requirements.

This training on FDA regulation of mobile medical applications is designed to provide attendees with an overview of the U.S. Food and Drug Administration's oversight of certain medical and healthcare mobile medical applications ("apps") designed for use on smartphones and other mobile computing devices. Attendees will learn to distinguish between those apps requiring FDA review and those not subject to regulatory oversight.

This 3 hour virtual seminar on China regulatory compliance processes for life science products will discuss the regulatory structure and requirements for compliance against China’s CFDA regulations for Pharmaceuticals, Medical Devices, Biologics and Combination Products.

This webinar on FDA social media regulations will discuss the best practices utilized by medical device, drug and other FDA and FTC regulated industries when using social media channels, i.e., Web 2.0, like Facebook, Twitter, YouTube and LinkedIn to promote products.

This training on global medical device regulations will discuss the regulatory framework for medical devices in US, EU and Canada. It will outline systematic methods to identify and meet regulatory requirements and streamline the regulatory process in these countries.

This medical device 510(k) training will help you understand the basics of 510(k) submissions and discuss how to develop and execute an approval strategy ensuring the fastest possible path to market.

This session will discuss in detail the Final Rule for the Physician Payment Sunshine Act, its impact and how to prepare for it. You will learn about reporting, certification and registration deadlines and what specifically needs to be reported or provided to CMS.

This webinar will provide an introduction to FDA’s regulation of product labeling and promotion; and the Agency’s position with regards to off-label promotion and how the Court’s decision in the Caronia case might affect the off-label promotion of Rx drug products and medical devices.

This social media compliance training for healthcare companies will cover the legal and regulatory requirements governing the use of social media. A scenario-based learning approach will be used to show how to create a successful social media team by selecting members from relevant stakeholders, and prepare social medial policies and procedures.

This medical device 510(k) training will explain the basics of 510(k) submissions and discuss tips, strategies and tools to develop and execute an approval strategy ensuring the fastest possible path to market.

This 90-minute webinar will explain FDA's 1997 guidance on 510(K) for device modifications and show how to integrate the evaluation into your design change program. The webinar uses numerous Warning Letters to illustrate the points, and helps you learn from others.

This EU MDD webinar will help you understand and recognize the most significant changes proposed for the new European Medical Device Regulations: 2012/0266 (COD). You will learn which procedural changes your company should be making now so that you stay in compliance throughout the transition period and reduce potential delays to new product introductions in the EU market.