Education Technology

Overview 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 record review process.

This 6-hour seminar will cover the latest SAMHSA and HIPAA updates which were released in January 2018 and December of 2017 respectively, and also cover multiple scenarios and FAQ’s relating to Substance Abuse Records, Mental Health Records, Alcohol Abuse Records, and the proper ways to secure this information and/or release this information. An overview of a comparative analysis will be presented comparing SAMHSA to the HIPAA laws relating to protected health information in general.

This 6-hour webinar takes the participants through HIPAA compliance from start to compliance. The first presentation explains the history of HIPAA, why it came into being and its evolution. This covers what HIPAA is, what steps have to be performed to be HIPAA compliant and what HIPAA compliance is. It also provides definitions to key HIPAA terms, how to define a Business Associate and how to contract with Business Associates. The second part of the first presentation is an overview of how to manage the HIPAA compliance project. The second session describes what a Risk Assessment is and how to perform the risk assessment. The materials take the participant through the factors of HIPAA compliance and how to perform a HIPAA Risk Assessment.

Statistical Process Control charts have been called the Voice of the Process. Progressive manufacturers utilize control charts to "listen" to their processes so that potentially harmful changes will be quickly detected and rectified. However, not all SPC programs deliver to their highest capability as there are many elements to get right to achieve maximum utility. Highly effective SPC programs combine technical competencies, such as using an appropriate chart and sample size for the application, with effective management techniques such as enabling operator buy-in and involvement. This webinar provides a comprehensive introduction to SPC methods and tools to help you deploy an effective SPC program.

Overview: This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject. Why you should Attend: It is not possible to present a complete treatment of project management in the span of 60-90 minutes. It is however possible to focus in on those most critical project management aspects that are critical to the success of any project. Without basic tools, it is not possible to effectively manage a project to the pre-determined end-date without turmoil and chaos.

Overview: This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained. FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient. FDA has set up regulations that address both data security and patient safety. We will show how 21 CFR part 11 considers both.

Overview: We often sample from a process or population in order to make an inference about the process based on the sample results. Selecting appropriate sample sizes often vexes many practitioners. This webinar discusses many issues present in any sample size determination. The webinar also discusses several common applications that require an appropriate sample size determination including estimation of product/process performance characteristics, hypothesis tests, acceptance sampling, Statistical Process Control charts, and reliability demonstration.

Pivot Tables have been a mainstay of the Excel program for two decades, and yet they remain a daunting and little understood tool. If you are a daily user of Excel, then at some point you will be faced with the challenge of data summaries and analysis. The 1st level of that process is sorting and filtering. And the 2nd level is Pivot Tables. Without them, you will be spinning your wheels trying to make sense of data. In this crash course, Andy Lanning will take you from intro to advanced; with many tips and tricks along the way! This course will demonstrate the Pivot Table window, the design process, the advanced level features, and also provided is a downloadable PDF guide with step-by-step instructions on each feature covered. Event link : https://www.traininng.com/webinar/-201242live?trainingregistry-SEO Contact Info Traininng.com LLC Email: traininngdotcom@gmail.com Phone: US: (510) 962-8903 Phone: Zurich: +41 - 43 434 80 33 Website : https://www.traininng.com

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.