Public Education

Overview: Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability. Specific areas presented: Look for Evidence The Post-it Exercise Pareto Chart Fish Bone Diagramming Process Reliability Modeling

Overview: This webinar will help you understand the critical ingredients for conducting an effective root cause analysis. You will learn about FDA expectations, tools and techniques, and tips for conducting and documenting root cause analysis. We will discuss the myths, challenges, and best practices for this critical process. We'll also cover the essentials of doing a failure investigation. Why should you Attend: CAPA is the cornerstone of quality improvement and it depends on an effective root cause analysis. Conducting an effective root cause analysis (RCA) can be a daunting task. And without a good root cause analysis, your CAPA will not result in the desired improvement.

Overview: In this webinar we will discuss the regulatory expectations that apply to the production and control of active pharmaceutical ingredients. The discussion will start with the introduction of ICH Q7, the internationally accepted GMP for APIs, discuss the international regulatory and compliance issues associated with this GMP and each of the main areas of ICH Q7 to include: personnel, buildings and facilities, process equipment, documents and records, materials, production and production controls, packaging, and laboratory controls.

Employers have always avoided the termination either because it is not easy to terminate someone or because it can be difficult to defend any allegations of wrongful termination. Cases of wrongful termination have emerged and increased since the late 2000 year.

Today we can be relevant one minute and out of business the next one. We are experiencing change at a faster and faster pace. It’s known as "accelerating acceleration," and those companies, leaders, managers, and workers who are slow to adopt or even resist change will be tomorrow’s Blockbusters, Sears and unemployed.

The Discretionary Effort Leadership Model is a comprehensive culture change model. It provides professional development for every manager and improves the sensitive conversations or touch points between a manger and an employee. Discretionary Effort is the difference between the level of effort, creativity, and problem solving one is capable of bringing to a task, versus the minimum effort required to just get by or make do, and still receive a paycheck. Each day, when an employee walks in the office door (or logs in remotely) and starts work, that employee makes a choice whether or not to give discretionary effort. It takes a special kind of leader to earn the gift of discretionary effort.

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. The logistics of importing products complicates the process further and you must know the consequences of your decisions. Some problems can cost you time and money, especially when you do not work promptly with the FDA. If you end up with having your entry "refused." There is no appeal. Then you face the possibility of additional steep fines by CBP and be blocked from the U.S. market.

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.