Education Technology

Overview: You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail: The following subjects will be covered in detail: How to compare two or more fields in a variety of layout styles How to sort and filter results How to perform ad-hoc grouping of information

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.

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability. FDA's 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries has been mixed. There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901300SEMINAR?trainingregistry-January-2018-SEO

Refund Policy This course aims to provide basic training for those concerned with pharmacovigilance, This course has been planned to provide you with the essential skills and tools to prepare and host a regulatory inspection and to facilitate the response and follow-up to the inspection outcome, findings (483s) and the necessary Corrective Actions and Preventive Actions (CAPA).

Overview: This webinar will give you the tools that you need to ensure that you understand data integrity issues and best practices for ensuring data integrity at your company. Why should you Attend: The FDA is increasingly focusing on data integrity issues, including data manipulation, when conducting facility inspections. Concerns over data integrity issues have resulted in the agency adding companies to the for-cause inspection list, and the FDA has found questionable data during in a significant number of these for-cause inspections. The FDA is noticing some electronic data manipulation in parts of its inspection program and is focusing on training its investigators to be more alert to data manipulation, Branding said.

Overview: FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA. Trolling for off-label information in social media, scrutiny of educational material under "safe harbor" and apparent conflicts of interest at a public event create a sink hole for firms even though it may seem innocent in your eyes.

Overview A strong credit culture: Focuses the organization-everyone on the same page Reduces organizational conflict and confusion-priorities Minimizes need for rigid controls Supports commitment to the organizational vision and mission Adds to the organization’s bottom line and enhances shareholder value

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.

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.

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.

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. To work with these challenges, it is essential to understand human behavior and the psychology of error as well as understand exactly where the weaknesses of the system are so that they can be improved and/or fixed.

This session is designed for health care executives, physicians and other health care providers who participate in and receive remuneration from Medicare, Medicaid, and other federal health care programs such as TriCare. Several recent cases bring home the realization that Stark II (the physician anti-referral law) is alive, still with us and as viable as ever, and it can be used as the basis of a False Claims Act action. As a health care executive, physician or other health care provider, you should be very concerned about the potential for Stark II, as well as the Anti-Kickback Statute, being used as the basis for an action brought under the Federal False Claims Act. In this webinar, you will learn about the elements of the Stark II law, along with the various exceptions and safe harbors that you can rely on for protection against enforcement under this law.

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.

Gain the insights and skills to know where your business stands today and where it’s heading tomorrow. In today’s unpredictable business environment, strategic leadership is not just for top management alone. It’s for: Managers who may be managing their entire team remotely, particularly for the first time Managers who want to increase their competitive advantage by anticipating their customers’ priorities, needs and expectations Managers who want to distinguish operational data from strategic data, creatively develop sources of information and increase their staffs’ flexibility and responsiveness Managers who want to broaden their perspective, improve flexibility without compromising quality and increase their department’s value to the organization

This seminar concentrates on five areas of wage and hour law: paying exempt employees, calculating gross wages under the FLSA, deducting from an employee's wages, the nuts and bolts of physically paying employees and changing payroll frequencies. Why you should attend Join renowned payroll expert Vicki M. Lambert, CPP for this 5 and one-half hour "Boot Camp" format, Wage and Hour Training for Payroll Professionals! By knowing and understanding Wage and Hour requirements, you can help protect your company from what could be a major financial calamity.

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.

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.

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.

However, all production processes exhibit variation that is, no two items are identical. What method can be used to reduce such variation? The classic and still most widely used method is called SPC or "statistical process control".