Education Training Courses

Overview: This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.

Overview: How CAPA's are executed and managed is crucial to maintaining a compliant organization. Inadequate CAPA processes continue to be a major GMP deficiency and consistently make the FDA's top five list for adverse observations. The primary objective of this webinar is to heighten awareness of the importance of the proper execution of the CAPA process to the organization, to the efficacy of the product and to the safety of patients and customers, and to describe the structure and function of an effective CAPA system.

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: Learn how to quickly spot violations in the workplace and how to correct them to OSHA standards by attending this webinar. The attendee will also be made aware of the most frequent violations, compliance strategies and the defense against citation. OSHA has a playbook that is used by each compliance and safety officer; the attendees will learn how to obtain a copy for free and tips for learning the content. Moreover, this webinar will give practical steps to an effective Injury and Illness Prevention Program (I2P2).

Overview: It has often been stated that "FDA inspects for compliance; European inspectors inspect for adequate science". Yet GMPs have been enshrined into law for many countries and a drug/biologic/medical device manufacturer should have a reasonable expectation of all inspections being the same.

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.

We can no longer stand by and let toxic people erode patient safety, our self-esteem, and the bottom line! This webinar will help you take immediate action! This problem is so severe that Dr. Kusy's research discovered: Only 1-6% of targets of incivility ever filed complaint 94% of leaders reported working with toxic people 92% rated the severity from 7 to 10 on a 10-point scale 45% said the uncivil person lashed out 2-3 times per week 51% of victims said they would likely leave as a result

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.

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.

What is Six Sigma? Six Sigma is a powerfully dynamic approach to process improvement in order to do things better, faster, and at a lower cost. It has been applied to every facet of business, ranging from production to human resources, to order entry and technical support. Six Sigma began in the mid-1980s at Motorola in response to the needs of a sale force faced with increasing customer dissatisfaction and competitive pressures. To address these issues, Motorola developed a set of formulas and tools to identify and measure performance based on your customer's inputs in order to increase efficiency.

Overview Do you have to communicate with people who make you want to pull your hair out (for those of us who still have hair)? You communicate very clearly and they just don't "get" it - its like they are not even hearing you. It can be so frustrating trying to get your message across. And then there are the people that talk too much without saying anything -they seem to talk just to hear themselves talk -it's so annoying. Or those that don't communicate at all -are you supposed to read their minds -its exhausting trying to get anything substantive out of them.

Overview Employee conflict costs organizations money, morale, and productivity. A rise in absenteeism and turnover is a likely sign that an organization is suffering from unresolved conflict. In this webinar, you will learn how to handle conflicts caused by the tasks of the job and relationships with coworkers. You will learn how to evaluate the seriousness of the conflict and how to appropriately intervene. In addition, the role of emotional intelligence, confronting employees in conflict and dealing with common issues of conflict at all levels of the organization will be considered.

Overview Make sure you are up to date on important payroll compliance issues. The webinar will discuss 2019 limits, the effects of the current legal case against the FLSA overtime changes; a look at unemployment issues for 2019. We'll also look at FUTA Credit Reduction states for 2018 returns. Changes to state minimum wages, tip credit and new players in the Paid Family Leave area will be addressed. A look at any effects of the government shutdown will also be included.

Overview: The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product. The advantages of "confidence/reliability" calculations are explained. Such calculations are demonstrated for Attribute data (pass/fail, yes/no data) as well as for variables data (i.e., measurements). If variables data is "Normally distributed" the calculations are extremely simple. The webinar explains how to handle "non-Normal" data, and provides the methods, formulas, and tools to handle non-normality.

Overview: The NACHA Operating Rules and Guidelines require that all participating depository financial institutions, third-party senders and third-party service providers that provide ACH services conduct an annual ACH audit to be performed by December 31 of each year (ACH Rules, Article 1). With the requirement that each participant conducts an annual ACH audit, this helps to ensure that electronic payments work safely and efficiently for all users. Why should you Attend: Due to a recently approved amendment to the NACHA Operating Rules, Appendix 8 has been removed from the Rules (Appendix 8 was the "guide" or checklist while completing the annual ACH Audit).

Overview: The ODFI is responsible for the registration process for any Third-Party Senders and nested TPS; registration is also necessary even if there is no TPS relationship. Why should you Attend: The registration process will promote consistent customer due diligence among all ODFIs, and serve as a tool to support NACHA's continuing efforts to maintain ACH Network quality.

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 Critical Path Analysis Value Stream Mapping Failure Mode Effects Analysis

Learn the tools, methods and exercises you can use to navigate Social Dynamics to make work life more stress free and enjoyable. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link - https://www.onlinecompliancepanel.com/webinar/How-to-Navigate-the-Social-Dynamics-of-Your-Organization-508486/APRIL-2019-ES-TRAININGREGISTRY

This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system. Without this understanding, water system control consists of a set of rules that often don't work and can cause very costly system downtime or even product recalls, and leaves the user without a clue as to what went wrong More: https://www.globalcompliancepanel.com/seminar/a-to-z-microbial-control-monitoring-validation-901945SEMINAR/?SEO

This 2-day seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this seminar is for you. We'll discuss regulatory requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls. We'll discuss best practices so you can start off on the right foot and always be prepared for an inspection. More: https://www.globalcompliancepanel.com/seminar/death-by-CAPA-Does-your-CAPA-program-need-a-CAPA-901954SEMINAR/?SEO