When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. For a long time there was no official guidance on what exactly is expected to maintain 'the validated state'. Areas Covered in the Session: Four approaches for analytical method transfer and testing Responsibilities of the transferring and receiving laboratory Develop...

The number of whistleblower cases continues to rise, and fewer reprisal cases are being dismissed. Since the introduction of the Whistleblower Protection Enhancement Act, there is new case law interpreting agencies’ responsibilities — and critical lessons you need to learn to defend personnel actions in your own agency’s whistleblower cases. Sam Vitaro will take you through new rulings, looking at whether the case outcomes sa...

DTC may be deemed as misbranding your product and, therefore, may not be marketed. Firms must be more sophisticated now in designing their advertising methods and messages. The days of looking at text alone for a magazine insert are long gone. You should pay attention to the components of your advertising in mass media, such as volume; images; information prominence and conspicuousness; speed of the message subliminal messaging and "the take a...

Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required. In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has established guidelines to allow early stage investigational products to be manufac...

Over the next four to six years, healthcare organizations will find themselves in the midst of a shift in the way that healthcare is administered and monitored. According to research, patients will begin taking ownership of their healthcare which will create a deep ripple effect across IT networks that enable the day-to-day activities of the military. To address these seismic changes, the military is looking at how technology solutions will su...

Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with. Also cont...

As an export compliance professional there are a wide variety of ways that you might find yourself needing to work closely with, and understanding the function of, your security department. This webinar is designed to strengthen your knowledge and build bridges between your export compliance and security departments. In order to do your job effectively, you need to work together with your counterpart in security. Your missions are the same, to...

Employees with disabilities should be held to the same standard of performance and conduct as all your other agency employees. How can you do this and ensure you aren’t violating the Rehabilitation Act? Federal employment law attorney Joseph Kaplan will guide you through, showing you how to manage employees with disabilities without the fear of disability discrimination. In just 90 minutes, you’ll become more effective and confiden...

In a 2016 PricewaterhouseCoopers survey of over 1400 CIOs, 84% stated they needed to address wider stakeholder needs and 77% found that technology was one of the top three influencers transforming stakeholder expectations for the business. Cost and budget pressures as well as citizen demands are far and away the primary drives of digital transformation in government. We’ll Discuss: Define the factors that are driving adoption of digital...

Why They Happen, How to Avoid Them, and What to Do if They Happen to You May 9, 2017 1:00-2:30 PM EDT Consent agreements are a feared, but recurring feature of the export control and enforcement landscape. The recent announcement of the ZTE consent agreement signals that the Trump Administration has not stepped away from this enforcement option and, in fact, is willing to apply it to new issue areas and regulatory regimes in order to further A...