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Supplier Management Solutions | Medical Device Manufacturers

Supplier Management Solutions | Medical Device Manufacturers

Location: , Germany
Category: Health and Medicine
Start Date: 03-15-2018 Last Day: 03-16-2018 Deadline for abstracts: 03-14-2018
Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment. How well do you understand the requirements for supplier management? Could you pass a regulatory audit or inspection without any issues? This course delivers the tools, templates, and methods to help participants…
21 CFR Part 11 Compliance Checklist- FDA Software Validation

21 CFR Part 11 Compliance Checklist- FDA Software Validation

Location: , United States
Category: Health and Medicine
Start Date: 03-14-2018 Last Day: 03-15-2018 Deadline for abstracts: 03-13-2018
This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers. The instructor addresses the latest computer system industry standards for data security, data transfer,…
Supplier Management Solutions | Medical Device Manufacturers

Supplier Management Solutions | Medical Device Manufacturers

Location: , Switzerland
Category: Health and Medicine
Start Date: 03-12-2018 Last Day: 03-13-2018 Deadline for abstracts: 03-11-2018
Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment. How well do you understand the requirements for supplier management? Could you pass a regulatory audit or inspection without any issues? This course delivers the tools, templates, and methods to help participants…
HIPAA Risk Assessment Checklist | HIPAA Compliance Training 2018

HIPAA Risk Assessment Checklist | HIPAA Compliance Training 2018

Location: , United States
Category: Health and Medicine
Start Date: 03-08-2018 Last Day: 03-09-2018 Deadline for abstracts: 03-06-2018
This two day seminar takes the participants through HIPAA compliance from start to compliance. The first presentation explains the history of HIPAA, why it came to 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. At the end of these presentations there will be a workshop…
Regulatory Requirements and Principles for Cleaning Validation

Regulatory Requirements and Principles for Cleaning Validation

Location: , Switzerland
Category: Health and Medicine
Start Date: 03-08-2018 Last Day: 03-09-2018 Deadline for abstracts: 03-07-2018
This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. This two day interactive course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors. The program will describe the requirements for establishing an effective cleaning validation program, including the development of a general policy, a "Cleaning Validation Master Plan"…
ISO 13485:2016 Implementation Workshop

ISO 13485:2016 Implementation Workshop

Location: , United States
Category: Engineering and Technology
Start Date: 03-01-2018 Last Day: 03-02-2018 Deadline for abstracts: 03-01-2018
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. This interactive session will include lectures, roundtable…
Connected Claims USA Summit 2018, Chicago, USA

Connected Claims USA Summit 2018, Chicago, USA

Location: , United States
Category: Business and Economics
Start Date: 05-21-2018 Last Day: 05-22-2018 Deadline for abstracts: 05-20-2018
As both the moment of truth for fulfilling the customer promise, and a significant cost centre, the claims process is a priority for insurance transformation. Connected Claims USA (May 21st and 22nd, Chicago) will explore how to deliver both operational efficiency and a seamless, omnichannel claims customer experience. Join this industry leading summit for insights on: Meet and Exceed Customer Expectations: deliver a seamless, easy to use claims customer experience, incorporating dynamic customer communication across digital and traditional channels, utilising customer data to reduce duplication and increase claims resolution speed Reduce Costs Through Efficient Processing: design strategies and implement technology…
Statistics for Non-Statisticians Course | Biostatistics Boston 2018

Statistics for Non-Statisticians Course | Biostatistics Boston 2018

Location: , United States
Category: Mathematics and Statistics
Start Date: 03-01-2018 Last Day: 03-02-2018 Deadline for abstracts: 03-01-2018
Why should you attend: Statistics is a useful decision making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on development of a drug or procedure, it is imperative that decision makers understand the theory and application of statistics. Many statistical softwares are now available to professionals. However, these softwares were developed for statisticians and can often be daunting to non-statisticians. How do you know if you are pressing the right key, let alone performing the best test? This seminar provides a non-mathematical introduction to biostatistics and is designed for…
Drug Products for Clinical Trials | FDA Approved Drugs List 2018

Drug Products for Clinical Trials | FDA Approved Drugs List 2018

Location: , United States
Category: Health and Medicine
Start Date: 03-01-2018 Last Day: 03-02-2018 Deadline for abstracts: 03-01-2018
In January 2006, FDA issued a final rule which specified that most pharmaceutical products (including biologics) produced for use in Phase I clinical trial studies were exempted from complying with GMP requirements, as defined in 21 CFR Part 211 under 21 CFR 210.2(c). Section 501(a)(2)(B) of the FD&C Act requires drugs, including IND products, to comply with cGMPs or if they are not manufactured in compliance with cGMPs, they are deemed adulterated. Based on this statutory requirement for manufacturers to follow GMPs, FDA issued cGMP regulations for drug and biological products in the Code of Federal Regulations (in 21 CFR…
Artificial Intelligence & Big Data Conference & Exhibition USA Nov 2018

Artificial Intelligence & Big Data Conference & Exhibition USA Nov 2018

Location: , United States
Category: Health and Medicine
Start Date: 11-28-2018 Last Day: 11-29-2018
The AI and Big Data Conference and Exhibition taking place o the 28-29th November at Santa Clara Convention Center is a showcase of next generation technologies and strategies from the world of Artificial Intelligence and Big Data, an opportunity to explore and discover the practical and successful implementation of AI and Big Data in driving forward your business in 2018 and beyond. The high-level conference will bring together forward thinking brands, market leaders, AI and Big Data evangelists and hot start-ups to explore and debate the advancements in Artificial Intelligence and Big Data and the impacts within the Enterprise, Consumer…
Aviation Festival 2018

Aviation Festival 2018

Location: , United Kingdom
Category: Business and Economics
Start Date: 09-05-2018 Last Day: 09-07-2018
The Aviation Festival is an exhibition and award winning conference that has grown to become one of the largest and most established aviation shows in the world today. The Festival continues to grow and attract a large audience of airlines, airports and travel technology companies from around the world and covers: - World Low Cost Airlines Congress: Still a large part of the festival, drawing in low cost carriers from around the world year on year - AirXperience: Innovation in passenger experience technology for the world's airlines - IFEC: The in-flight entertainment and communications show - Air Retail Show: Retail…
HIPAA Compliance - Clear, Complete, Step-by-Step

HIPAA Compliance - Clear, Complete, Step-by-Step

Location: , United States
Category: Health and Medicine
Start Date: 02-26-2018 Last Day: 02-27-2018 Deadline for abstracts: 02-25-2018
Organizations of all types and sizes continue to struggle needlessly with HIPAA Compliance. For example, HIPAA Risk Analysis - Risk Management is the basis of the HIPAA Compliance Program of every Covered Entity and Business Associate. But mandatory HIPAA Compliance Audits conducted by the Office for Civil Rights (OCR), the HIPAA enforcement arm of the U. S. Department of Health and Human Services (HHS), found 94% of Covered Entities failed the Risk Management Audit and 87% failed the Risk Analysis Audit. And every audited Covered Entity knew well in advance that it was on the short list to be audited,…
What is a Clinical Trial, Regulatory Challenges Faced and How to Successfully Manage them?

What is a Clinical Trial, Regulatory Challenges Faced and How to Successfully Manage them?

Location: , United States
Category: Health and Medicine
Start Date: 03-22-2018 Last Day: 03-23-2018 Deadline for abstracts: 03-20-2018
This course will start with an introduction to the different types/phases of clinical trials. The different types are intended to test for the safety and efficacy of the treatment in question. The key document in any clinical trial is the study Protocol. The general contents of this document are specified in the FDA Regulations - Code of Federal Regulations (CFR) section 21. This document is key to everything that goes on during the trial. It is recommended that if you have anything to do with the trial you should review this document. During a clinical trial there can be a…
Good Clinical Data Management Practices (GCDMP)

Good Clinical Data Management Practices (GCDMP)

Location: , United States
Category: Health and Medicine
Start Date: 02-22-2018 Last Day: 02-23-2018 Deadline for abstracts: 02-20-2018
Why should you attend: Good clinical data management (CDM) is paramount for a successful research. After all, Garbage In, Garbage Out (GIGO). CDM is involved in all aspects of collecting, processing, and interpreting information. There are many types of computer applications and database systems to support data collection and management. However, there are elements of Good Clinical Practice that apply across the board. Review and approval of drugs or devices by regulatory agencies requires the assumption that the data presented are valid and reliable. Integrity of the data is paramount to ensure confidence in the results and conclusions you will…
The Value of a Human Factors Program

The Value of a Human Factors Program

Location: , United States
Category: Health and Medicine
Start Date: 02-22-2018 Last Day: 02-23-2018 Deadline for abstracts: 02-20-2018
This seminar will explain the implementation of ISO 62366 and the regulatory expectations discussed in the 2016 FDA Guidance for a compliant human factors/ usability program. The ISO 62366 is an "Consensus" Standard, making it a gold standard for regulatory submissions. We will look at other reference points regarding HF, like AAMI/ANSI HE75:2009 and how HF Engineering include consideration of: Device Users Use Environments and User Interfaces Preliminary Analyses Exploratory HF/Usability Evaluations Hazard Mitigation and Control We will look at the implication of HFE through Design Controls in the QSR: Design input -includes "needs of the user and patient" Design…
Evolution of the Quality Management System - How to go from Surviving to Thriving

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

Location: , United States
Category: Education
Start Date: 02-22-2018 Last Day: 02-23-2018 Deadline for abstracts: 02-21-2018
Using lecture, discussion, and exercises, this 2 day seminar will focus on taking your QMS from surviving to thriving. We'll move from understanding the regulatory requirements, how to create your QMS structure, process thinking, and developing your improvement strategy. We'll discuss tools and techniques for improvement and how to measure your progress. Why you should attend: 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…
A Risk Based Approach To Data Integrity

A Risk Based Approach To Data Integrity

Location: , United States
Category: Health and Medicine
Start Date: 02-22-2018 Last Day: 02-23-2018 Deadline for abstracts: 02-20-2018
The impact of Data Integrity issues on a regulated company can be significant: it can result in recalls of products, warning or untitled letters, import alerts, injunctions, seizures, legal action, etc. These regulatory actions can have significant financial impact to the company. However, and most importantly, data integrity issues can lead to potential patient harm!! Defined by the Medicines and Healthcare Products Regulatory Agency (MHRA) as "the extent which all data are complete, consistent and accurate throughout the data lifecycle", data integrity is increasingly the focus of regulatory agencies round the world. Companies must now ensure that they are appropriately…
Project Management for Non-Project Managers

Project Management for Non-Project Managers

Location: , United States
Category: Health and Medicine
Start Date: 02-20-2018 Last Day: 02-21-2018 Deadline for abstracts: 02-19-2018
This two-day seminar will begin by laying the foundation for the subject by first defining what a project is and then discussing the unique roles that the project manager must assume along the length of any project. The Triple Constraint, the most fundamental of project management principles, will be explained in detail with examples and tools provided that can be used to integrate the principle into any project management process. Each stage of project management - Initiate, Planning, Executing, Monitoring and Controlling and Closing will be detailed. Activities highlighting each step of the process and key concept will be presented…
Risk Management in Medical Devices Industry

Risk Management in Medical Devices Industry

Location: , United States
Category: Engineering and Technology
Start Date: 02-15-2018 Last Day: 02-16-2018 Deadline for abstracts: 02-13-2018
Gaps, incorrect or incomplete implementation of software can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical device software in a regulatory compliant environment. Software risk management has to be embedded into the bigger scope of overall risk management. Therefore this course will additionally address the system level risk management and the resulting interfaces…
Tougher Import Rules for FDA Imports in 2018

Tougher Import Rules for FDA Imports in 2018

Location: , United States
Category: Health and Medicine
Start Date: 02-15-2018 Last Day: 02-16-2018 Deadline for abstracts: 02-13-2018
Background: FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures. Firms that fail to understand and properly execute an import and export program find their shipments delayed, detained or refused. As of December 2016, FDA and CBP officially implemented the Automated Commercial Environment (ACE) entry filing system. You either meet ACE requirements or face entry refusals and monetary penalties of up to $10,000 per offense. Other factors can derail the expectation of a seamless import entry process. The course covers detailed information…

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