Public Education

Overview: This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described. Why should you Attend: Testing software to prove that it works and has no bugs is not sufficient to obtain FDA approval. There are additional analyses and tests that FDA feels are necessary to prevent user injuries. These requirements were developed after analysis by the FDA of many recalled medical devices. In this webinar you will learn the testing that is required in addition to functional tests to produce a validated software product.

Computerized systems are used throughout the life sciences industry to support various regulated activities,which in turn generate many types of electronic records. These electronic records must be maintained according to regulatory requirements contained within FDA's 21 CFR Part 11 for US jurisdictions and Eudralex Volume 4 Annex 11 for EU jurisdictions. One of the requirements for such compliance is the generation and review of audit trails. Thousands of audit trail records can be generated on a daily basis.

Harm to patients and damage to a company's reputation are the two most obvious consequences of substandard product. Yet, many companies pay too little attention to these problems, preferring short-term gain over long-term reputation and profitability. Within companies, it is common to hear the argument that quality is a cost center and does not directly contribute to the company's profits.

The content of the webinar will focus on the practical and how to best thoroughly accomplish an effective CAPA system, also this webinar highlights the various regulations governing CAPAs, how CAPAs are successfully initiated and managed, how CAPA is an integral part of the quality system, and how an effective failure investigation and root cause analysis is accomplished.

Overview: This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies. Why should you Attend: Human Error occurs in all settings. In the world of pharmaceutical manufacturing, the result of that error can result in loss of product or at the most extreme, injury to patients. Human is a frequent occurrence in pharmaceutical manufacturing. It occurs even when every obvious preventive actions have been employed such as effective compliance documentation development and training.

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.

If you avoid arguments, lie to keep the peace, or believe that hiding behind your desk is better that disagreeing than this webinar is for you. Conflict is not a bad thing, in fact it can a truly positive tool in your professional toolkit if you let it. By taking hard conversations, feedback, and discomfort and transforming it with mediation and compassion you can grow in ways you never before imagined.

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.