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  • 61 Request Info

    How can companies allocate scarce resources

    Overview: This webinar will help you understand the critical ingredients for conducting an effective root cause analysis, also you will learn how to Analyze and document the root cause of the problem. Why should you Attend: The billions of dollars spent by industry annually on quality / GMP are not providing the product safety or efficacy seemingly promised. And for most companies, the fixes are not rocket-science, but proper up-front risk-based, closed-loop failure investigation / root cause analysis as an integral part of CAPA, Validation and Quality Management Systems / cGMP planning, implementation and execution.
  • 62 Request Info

    How an Organization can remain Compliant with these Regulations

    Overview: Among those educational requirements are a course in Introductory GMP upon employment at a pharmaceutical company, and annual refresher GMP training. Why should you Attend: The laws that govern Good Manufacturing Practices (GMP) are a cornerstone of pharmaceutical production. Still, many companies fall short of the requirements that are written into US, UK, European and other laws, which can have disastrous consequences for patient health and a company's reputation, not to mention the resultant losses in revenue due to fines, declining sales and withdrawal of products from the market.
  • 63 Request Info

    What Sponsors Expect and How to Meet their Expectations

    Overview: It is essential for industry to employ efficient and accurate strategies for monitoring outsourced projects to minimize the chances of receiving warning letters from competent authorities. Companies should have robust structures in place for successful vendor selection, contract design, and quality monitoring and risk minimization when outsourcing activities in GXP areas to remain compliant. Areas Covered in the Session: Discover Tools and Processes to Manage CROs/other Vendors Gain an insight for CROs/other Vendors of what Sponsors Expect and how to Meet their Expectations
  • 64 Request Info

    Process Validation General Principle & Practices | USA 2018

    The process validation guidance document defines the need for this stage: "After establishing and confirming the process, manufacturers must maintain the process in a state of control over the life of the process, even as materials, equipment, production environment, personnel, and manufacturing procedures change." Manufacturers should use ongoing programs to collect and analyze product and process data to evaluate the state of control of the process.
  • 65 Request Info

    Root Cause Analysis: Foundation of Investigations and CAPA

    This seminar will be of benefit to anyone working in a GMP regulated environment on global or domestic scale within the pharmaceutical and medical device industry. This includes quality, validation, engineering, manufacturing, and management personnel from sponsors and contract manufacturers (CMO) alike. This is anyone who wants to improve their ability to solve recurring problems should attend this training. Additionally, those who are actively involved in performing, overseeing, auditing, or managing investigations will find this course extremely beneficial.
  • 66 Request Info

    ISO 13485:2016 Implementation Workshop | Conference 2018

    The medical device industry is in the midst of major change, with the publication of the FDA's UDI Regulation, the first revision to the ISO Quality Management Systems standard in over a decade, and the upcoming changes to the EU's Medical Device Regulation expected to be passed later this year. All of these events have far reaching effects on Quality Management Systems so it is critical to understand what has changed with in ISO 13485: 2016 in order to create a comprehensive quality plan for your organization to ensure continued compliance and certification.
  • 67 Request Info

    Computer Systems Validation Conference 2018- 21 CFR Part11

    Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV.
  • 68 Request Info

    Assuring IT Regulatory Compliance

    The concept of industrial compliance with applicable laws and regulations deals with obeying the statutory requirements to which the entity is subject. Compliance infers acceptance. Societal expected behavior acceptance requires value(s) conformity to established norms.
  • 69 Request Info

    Practices to Support FDA Computer System Validation

    This session will address the specific way of documenting your computer system validation work to ensure it meets FDA requirements and can pass an inspection, also this webinar will help you understand the FDA's requirements for good documentation, including how to handle change control and the importance of audit trails, you will learn how to create and maintain good documentation that meets FDA compliance standards.
  • 70 Request Info

    Webinar on Medical Device Single Audit Program (MDSAP) - All You Need To Know

    What is MDSAP and where is it going? Will it eventually touch my business anywhere in the world? MDSAP is creating a playing field among regulatory bodies around the world. That playing field consists of the 6 critical regulatory bodies that are participating in the development of future considerations for an equivalent and reciprocal set of conscript elements of compliance to GMP conditions of operation. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Medical-Device-Single-Audit-Program-MDSAP-All-You-Need-To-Know-509189/MARCH-2018-ES-TRAININGREGISTRY
  • 71 Request Info

    Does the Boss Really Have Horns?

    Overview: Managers are usually promoted to their role because of their technical skills and not their people skills. In fact, studies have shown almost a decade gap between when people get promoted and when people begin to seek out leadership skills. If you can understand where your boss is in the process, you may be able to help them become the boss you want them to be.
  • 72 Request Info

    Driving a Quality-Lean Steering Committee

    Overview: This session demonstrates how to develop, manage, and implement an effective quality Lean Management System (QLMS) steering committee. Attendees will observe the development of the key components of a steering committee. Several successful examples across various business types will be shared. Attendees will walk away with a model that they can apply to their own organizations.
  • 73 Request Info

    Failure Modes and Effects Analysis

    Overview: Failure Mode and Effects Analysis (FMEA) is a powerful tool for product quality. It has its roots in reliability but has expanded into other areas including process control. The primary purpose is to investigate failures and the way (the mode) they happen. This leads to an evaluation of the failure's effect on the product or process and measures to manage it.
  • 74 Request Info

    Networking for Fun and Profit

    Overview: Most people lack the basic networking skills necessary to do their jobs properly.These networking skills help us in many areas of our jobs. To begin, networking skills actually improve interpersonal communication skills with coworkers and supervisors. At the core, networking skills are about how to help people get to know you, like you, and trust you. These skills help ensure that every interaction you have with people leaves them happy that they interacted with you.
  • 75 Request Info

    Best Practices for Foundational Employee Success

    Overview: The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions. Onboarding new or transferred employees in a Pharmaceutical Good Manufacturing Practices (GMP) environment and ensuring compliance with these requirements create some unique challenges.
  • 76 Request Info

    Quality Audit According to Gxp-GMP Requirements

    Overview: GxP/GMP regulations are required to be used in regulated industries such as food, pharmaceutical, medical devices, and cosmetics. GMP regulations describe required quality management system for production and testing of products in these regulated industries. The purpose of the GMP regulations is to ensure that a product is safe and meets its intended use.
  • 77 Request Info

    Statistical Sampling Plans - Methods and Applications

    Acceptance sampling plans are important tools for manufacturers. Effectively used they can help reduce costs while assuring quality and controlling risks. Unfortunately, this rich field of techniques is not as prominent as it once had been. As a result, quality practitioners don't always appreciate the wide range of available options or understand how to choose among alternate statistical sampling plans. Click to Continue Reading: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901573SEMINAR?trainingregistry-April-2018-SEO
  • 78 Request Info

    Managing Your FDA Inspection: Before, During and After

    FDA's inspection program follows well-established procedures and conducts the inspections with as much consistency as possible. FDA trains its investigators from day one. During the first six months, they attend extensive classroom and hands on training. FDA investigators learn basic skills. As time goes on, special training is given and the field staff use detailed reference materials to guide their thinking, actions, decisions and conclusions. If you understand FDA's management of its investigators and inspectional process, you can keep your establishment ahead of a needless regulatory disaster. FDA conducts inspections with standard operating procedures and detailed information on how to handle almost any situation the FDA investigator may face. Click to Continue Reading: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901411SEMINAR?trainingregistry-April-2018-SEO
  • 79 Request Info

    Evolution of the Quality Management System - How to go from Surviving to Thriving

    Many companies struggle to establish and maintain a Quality Management System (QMS) that is both efficient and effective. An ineffective QMS leads to disastrous consequences such as medical device reports, recalls, 483s, and warning letters. An ineffective QMS can result in serious consequences for your customers leading to dissatisfaction, serious injury, or even death. It is imperative that medical device companies can effectively establish a QMS. And an inefficient QMS results in wasted time, money, and missed opportunities. In this 2-day seminar, we will use lecture, exercises, and discuss to learn the fundamentals of a Quality Management System and how you can take your program from surviving to thriving. A thriving QMS can help you achieve your compliance objectives and improve product quality, leading to higher customer satisfaction and business results.
  • 80 Request Info

    HIPAA Training for the Compliance Officer 2018

    This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule and any other applicable updates for 2018 and beyond. There are an enormous amount of issues and risks for covered entities and business associates these days. I will speak on specific experiences from over 17 years of experience in working as an outsourced compliance auditor, expert witness on multiple HIPAA cases, and thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information. Click to Continue Reading: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901510SEMINAR?trainingregistry-April-2018-SEO