Education Technology

FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform. If the information can reach a consumer, FDA cares, even if you did not publish the information. Firm's need to watch for promotional trespassers. Websites, chat rooms, op-ed articles or even your own postings in social media can cause your product to be misbranded, i.e., illegal. 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?

The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point". This is a major headache. How can companies make that determination? How can they trigger such an analysis over the major change or the series of smaller changes.

This webinar explains how to choose and justify a sample-size for Lots that are included in Process Validation studies. The statistical methods discussed during the webinar include the following: Confidence intervals Confidence / Reliability Calculations (for variables & attributes) It then explains how to analyze those samples in such a way that they provide statistically valid final %Reliability for the production Process itself. One example is worked through completely.

Quality Manuals are too often long documents that contain little more than a regurgitation of the standard requiring the manufacturer to have one. They end up being daunting to employees, confusing to everyone except those in Quality, difficult to maintain, and ultimately, a failure to meet the intent of the standard. In this webinar, attendees will learn to focus on the true intents and requirements for having a Quality Manual, and how to meet them efficiently.

Lets be honest here you probably have people in your life that, if they would just go away! your life would be easier? Interacting with them is exhausting and frustrating - even thinking about interacting with them is discouraging and causes you to despair the situation will never get any better. We all have those people in our lives. The reality is, having them out of your life is not practical - they may be your boss, staff, colleague, customer, vendor, friend, or family member.

You don't have to have peace in your life or a calm mind in order to use the tool that is mindfulness. Mindfulness is about increasing awareness to manage reactions, emotions, and perceptions. In the work environment this means increasing productivity, avoiding burnout, and retention. Too often we believe the lie that we should first have it all together and then we will be more rational and centered when in the reverse is true. In this webinar we will explore why that is true, how to increase your mindfulness inside and outside of work each day, and how to make a mindful approach second nature now.

Of course, we all have customers and we know we need to maintain a good relationship with them. But how do we do that? Yes, software systems are useful tools, which help us track the details. Our strategy for staying connected with customers is much more important. Each customer is unique. How do they want to be contacted? What are their needs? What affects their business today? Have their needs changed since we worked with them initially? What results did they get from working with us? Do they need additional products or services? The questions mount up, and that's the key to managing these vital relationships. Learn to think more strategically about sustaining long-term healthy relationships and grow your business with every interaction.

Overview This webinar discusses the definition of a differing site condition and why there is a need for a Differing Site Conditions clause in a construction contract. The webinar sets forth the history and purpose of the clause and examines the modern Differing Site Conditions clauses and the changes over time. Why should you Attend This webinar provides a thorough discussion of the Differing Site Conditions clause and how the typical understanding of this 90 year old clause is being eroded by Court and Board decisions. The differing site conditions clause was created by the U.S. Federal government in 1926, in regards to construction contracts. Over the years, the Courts and Boards of Contract Appeals have been slowing changing the interpretation of risk allocation under the clause. A series of Court and Board cases have increased the contractor’s risk concerning differing site conditions.

Overview Many leaders struggle to understand that happiness doesn't equal engagement. Just because an employee is happy because they are provided what they ask for, doesn't mean they are engaged. Entitlement and accountability are two-way streets between leaders and employees and creating an irresistible culture helps easily align which street your team is taking. Accountability starts with leaders, and entitlement does too, but it doesn't end with leaders and there are daily techniques to ensure team members are stepping into engagement when the door is opened for them.

This Bank Secrecy Act (BSA) program training will guide attendees through the methods to train each segment of the bank's or credit union's employees annually on Bank Secrecy Act. It can be used as a "Train the Trainer" course or as annual training for all employees. Two of the greatest fears known to man: the fear of dying and public speaking. Jerry Seinfeld said that most people would rather be in the coffin than giving the eulogy. However, a sound BSA program requires annual updates: board appointed BSA officer, a BSA policy, face to face training, and a system of internal controls (checklists) to monitor for suspicious activity.

Employer federal income tax withholding is intended to collect, throughout the year, the approximate the amount of the employee's tax for the year. The wage bracket and percentage methods are the primary methods for computing the amount to withhold, but sometimes they just don't seem to get the right result.

Emphasizing the importance of long-term strategic decision-making, the strategic decision-making mindset program is designed to improve managers' judgment and critical thinking skills using proven approaches, cutting-edge research, and behavioral economics. Participants will understand the decision-making process from start to finish, with the ability to recognize cognitive biases that inhibit good decisions. This strategic decision-making program enhances participants' capacity to make well-thought-out individual, group, and organizational decisions.

Emotionally intelligent people are self-aware and are alert to the verbal and non-verbal signals of others, ensuring that their communication skills and ability to build relationships are more effective. Emotional intelligence is a general set of skills that can be applied to anyone and any environment. Understanding EI and mastering the skills involving emotional intelligence will greatly help you and your team in difficult situations. It has been shown that, Emotional Intelligence or EI, can be even more critical than the power of the cognitive brain usually measured with IQ.

Directors and Managers today are continually challenged in managing their union workforce. It remains extremely important for them to have and utilize their available tools and learn new tools, in order to effectively manage their employees. The information presented in this webinar will save time and money for your organization as Managers will perform more effectively, as they embrace positive employee and labor-management relationships.

You will leave this webinar with a clear understanding of what drives these emotional outbursts and how to use a 3 step process to deal with them constructively and productively. You will know how to use the Art of Emotional Aikido - you'll be able to protect yourself from even the harshest attacks. You will be able to leave "work at work" and enjoy your personal time without having to replay events of the day.

Overview: CFIA is moving quickly to automate their compliance systems, tightening timelines for faster recall and crisis handling while enhancing many of their food safety regulations to compete and sync with global players This session will explore history, timelines, compliance priorities, nuances on rationale for changes, partnering agreements and many other aspects within the new regulations. We will cover the new portal, requirements, fees, penalties and future plans.

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Importing FDA regulated products requires careful planning before you even start. Registration, product compliance, record and data submission must be exactly correct or your product will be detained. Likewise, the U.S. Customs and Border Protection (CBP) must be precise or your entry is not going anywhere. Some mistakes are common, others reflect a lack of understanding of how FDA and Customs and Border Protection (CBP) operate a joint program.

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 6-hour virtual seminar includes a presentation of the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products. The concepts and information presented will be mainly concerned with statistical process control: obtaining monitoring information (data) that is objective, unbiased, and useful for decision making. An emphasis will be placed on the set-up and use of control charts.