Overview: One big issue is how you patrol and control what someone else is saying about your product in a public forum. Once the off-label information is out there, what is scope your responsibility? Why should you Attend: What is considered "off-label" Using social media website "likes" and links Direct to Consumer promotion pitfalls Fair and balanced information Areas Covered in the Session: Understand how social media is labeling Learn how third parties place you in jeopardy Understand FDA's concern…

OVERVIEW Investigative report writing actually begins from the very beginning of your investigation and continues throughout the process. This webinar will discuss the intricacies of writing the critical final report of your investigation that may be discoverable (all documents that must be provided to opposing counsel in case of a lawsuit) if an employee files a formal charge with the EEOC or your state’s human rights department, or if you are sued. A number of critical actions are required as part of your investigation.…

OVERVIEW It’s a TNT – Time-Numbers-Technology – Driven & Distracted Brave New World, when “Everything Happens NOW.” While some see a half-full glass of unprecedented access and data…others perceive rampant “Infomania” — continuous stress and distraction caused by the combination of message overload, incessant interruptions, and “Time Urgency Syndrome.” Through his Fun-Interactive-Thought-provoking (Get FIT) program, let the Stress Doc help you transform the MA&DD-ness: Gain tools for 1) assessing individual/digital distractions in the workplace and 2) designing self-monitoring and team building activities for work and strategies for a…

An in-depth comprehensive investigative report memorializes the investigation, and can be evidence that an investigation actually occurred, which helps you in minimizing liability. Our upcoming webinar discusses critical elements of an investigative report and how to document the facts that the organization requires in case of legal disputes. The webinar covers the following key areas: Frequently missing elements from reports How to reach conclusions and the required follow-up actions How to include everything in the investigative report writing for minimizing…

Building a comprehensive compliance programme can be a tedious process. Compliance professionals recognise the need to manage compliance and business risks, but often do not take into consideration the current compliance trends or embrace the changes in the market when they set up their processes and programmes. During this webinar, Scott Lane, CEO & Chairman and Andrew Henderson, VP of Products, from The Red Flag Group will be offering practical advice on how to build an effective compliance framework taking…

OVERVIEW You may have heard that most employment is at-will, but what does that mean? If you employ your workers “at-will”, does that mean you can fire them whenever you want? Does invoking the employment at will doctrine protect you from wrongful termination lawsuit? Attend the webinar to know. WHY SHOULD YOU ATTEND Many employers make the mistake of assuming that because they hired an employee “at-will”, terminating that employee will be a done deal—and they often end up defending…

OVERVIEW Many employers make the mistake of assuming that because they hired an employee “at-will”, terminating that employee will be a done deal—and they often end up defending a wrongful termination claim. Our upcoming webinar discusses the extent and limits of employment-at-will, including the statutory exceptions and contractual provisions. The webinar covers the following key areas: Identifying situations falling outside of at-will employment Rights and obligations of employers and employees Scope of employment-at-will, anti-discrimination laws and case examples LEARNING OBJECTIVES In…

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.  This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability. FDA’s 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries has been mixed.  There…

Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance. A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc. This webinar will analyze each of these necessary elements of the batch…

Overview: The Phase 2 HIPAA Compliance Audit, increasing breaches of unsecured protected health information and rampant medical identity theft reveal a national crisis in HIPAA compliance. The Office for Civil Rights (OCR), the HIPAA enforcement arm of the U. S. Department of Health and Human Services (HHS), is ramping up enforcement. And a basic HIPAA requirement, Risk Analysis - Risk Management, is the key to protecting your business, whether you are a covered entity or a business associate. Why should…