Overview: This course will help you to use statistics correctly and minimize compliance risk. Statistical tools and techniques are very commonly used to help measure and improve the quality of a firm's process and product. If statistical analysis is not properly performed and/or understood, a firm can run the risk of distributing product to the market that ultimately fails eventually resulting in lost time and money. And of course, with statistics, practice makes perfect. During this two-day HIGHLY interactive training program, participants will be given the opportunity to apply statistics learned to real-world example data sets! The program begins by…

Overview: Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented. This webinar will provide a good understanding on how to effectively prepare, conducts and document method validation experiments for FDA and ISO 17025 compliance. Reference material for easy implementation: SOP: Validation of Analytical Methods Checklist: Validation of Analytical Methods 65-page Primer: Validation of Analytical…

EAS 2012, the 80th European Atherosclerosis Society Congress, offers an exciting combination of high-level scientific learning from world experts with a chance to experience the cultural hub of Milan. With plenty of time for networking, participants at this specialised atherosclerosis congress will receive the latest updates on the complex and multifactorial pathogenesis of atherosclerosis. Join us at Milan’s new and ultra-modern Milano Convention Centre, rated among the largest conference facilities in Europe and worldwide.

Following the overwhelming success of the conference MEESEC 2011, Fleming Gulf Conferences is back with its 7th Middle East Energy Security Forum this year to be held in Abu Dhabi . Seventh in a series of successful annual forums, the event will provide an unparallel platform for global security professionals in energy sector, highlighting latest strategies and technologies which can be implemented to effectively mitigate threats. Identify and evaluate threats, explore the best practices in developing plans and update yourself on the latest security technologies available at the market, join MEESEC 2012. Gain an in-depth examination of security landscape in…

"A History of Alcoholics Anonymous" will be presented on Tuesday May 29, 2012, from 7:30 pm to 9:00 pm; by James Balmer; President, Dawn Farm. This program will present a fascinating overview and slide show of the history and development of the Alcoholics Anonymous (A.A.) program, including its founding and growth. The discussion will include a brief overview of the Twelve Steps of A.A. (Dawn Farm is not affiliated with any twelve Step program.) This program is part of the FREE, annual Dawn Farm Education Series. Our presentations offer helpful information that supports people with alcohol and other drugs addiction…

Welcome to our European Lab Automation congress and exhibition, Europe's largest event dedicated to automation within life science. Offering over 150 scientific presentations across 8 different conference streams linked with an exhibition containing more than 150 equipment vendors, ELA aims to highlight and showcase the latest in automated instruments and workflows. Life science researchers and professionals are presented with an unparalleled opportunity to foster technological discussions and scientific collaboration. Registration for ELA 2012 is now open, with all conference delegates having the opportunity to attend all 8 conference streams.

This 90-minute webinar on HIPAA Breach Notification will show how to create an effective breach notification policy for your organization and how to follow through when a breach occurs. You will learn about the kinds of threats that exist for PHI, information security methods you can use to keep breaches from happening, and be in compliance with the HIPAA Security Rule as well. Why Should You Attend:- The HIPAA Breach Notification Rule has been in effect since September 23, 2009 and most organizations are not prepared to respond to a breach of PHI and report and document it properly. We…

Aimed mainly at otolaryngologists consultants and senior trainees but also attracting a wider audience of thoracic surgeons, interventional respiratory physicians and speech and language therapists, the meeting will feature an outstanding panel of international and UK speakers bringing together delegates from all over the world.

"Teens Using Drugs: What To Know and What To Do" is a free, ongoing, two-part series designed to help participants learn to understand, identify and address adolescent alcohol/other drug problems. Part 1 provides information on how to understand and recognize the signs of a teen substance abuse problem and includes a short video. Part 2 provides information on what should and should not be done when a teen substance abuse problem is recognized, and concludes with a short open talk by a young person in recovery. The series is presented on the first (part 1) and second (part 2) Tuesday…

Overview: Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted. This presentation will discuss what advance preparation is needed on the part of the auditor, and discuss what the auditor should look for during the audit. Since documentation is often an issue, a discussion of documentation problems will be…

Overview: Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted. This presentation will discuss what advance preparation is needed on the part of the auditor, and discuss what the auditor should look for during the audit. Since documentation is often an issue, a discussion of documentation problems will be…

Overview: This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for your own needs. This session will make you a better Excel user, saving you time and costs. Areas Covered in the Session: Develop spreadsheet applications that are GxP compliant. Avoid 483s and warning letters. What does and does not need to be validated. Learn how to use…

Overview: Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted. This presentation will discuss what advance preparation is needed on the part of the auditor, and discuss what the auditor should look for during the audit. Since documentation is often an issue, a discussion of documentation problems will be…

This 90-minute webinar will review the 21 basic elements that need to be addressed in the traditional 510(k) submission, as required by the FDA. Why Should You Attend:- The U.S. FDA mandates that the traditional 510(k) submission address 21 basic requirements. The "Special" and "Abbreviated" 510(k)s must also address them, but in different ways. In addition, the FDA Task Force has identified several problem areas with the existing medical device 510(k) process, leading to the growing push by the Agency to strengthen the 510(k) process. What can companies do proactively to address these concerns and better ensure a smoother review…

Antibody drugs play a more and more significant role in biopharmaceutical industry around the world. Over $50 billion dollars sales in the world market, it keeps a rapid growth with the speed over 20 percent per year. The ballooning of antibody shows that: with the rapid development of science and technology, antibody must be the hot in the next decade. With the profound influence of previous Pharma manufacturing summit, based in Shanghai China Antibody China Summit 2012 is about to become one of the most influential international summit. We would like to be committed to the prosperity of industry and…

This 90-minute presentation will cover the FDA Quality System Requirements for software used in medical devices. The presenter will review FDA guidelines on software verification and validation and discuss methods to verify and validate even complex software. Why Should You Attend:- Software problems are now the third-leading cause for recalls of medical devices. Most recalls are because of incorrect verification and validation for safety. Most of the knowledge on how to do a comprehensive V&V is not widely understood. Software design is a complex set of interactions within the device, with the connecting devices, and with users of the device.…

Overview: The FDA's Quality System Regulation (QSR) prescribes the Quality Management System for a medical device manufacturer who markets in the US. ISO 13485 covers the rest of the world. The webinar describes management responsibility by reviewing the regulations and the reasoning that FDA published. Management responsibility, in QSR, has five major components: Quality Policy, Organization, Management Review, Quality Planning, and Quality System Procedures. The webinar covers each of these topics and provides a list of things you should consider in your implementation. Why should you attend: One of the most common areas for FDA Warning Letters is Management Responsibility.…

Overview: This webinar is not a project management certification course. It is designed to provide the tools necessary to assist those designing a result or deliverable to achieve that end. It will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale. Three of the most common tools will be discussed. Common variants such as "dashboards" will also be presented. A very simple approach using common Excel- or Word-type PC applications programs that…

Overview: This CAPA training program helps you to understand, in 10 easy steps, the entire CAPA process. It includes elements of Quality Tools, Team Effectiveness, Awards & Recognitions, and Verification & Validation of actions taken. Attend this webinar to grasp the A to Z of CAPA and learn how to implement & manage it for success. Why Should You Attend: We have found out, through auditing many organizations world-wide that the organizations are pretty good when it comes to corrective actions yet they are not nearly as good when it comes to the preventive actions. This webinar should provide you…

It’s a great pleasure to invite you to the “Cadmium Symposium 2012”, that will take place in Sassari (Sardinia) Italy, from 8 to 9 June 2012. Cadmium is a heavy metal with a high toxicity. It is toxic at very low dose and it has acute and chronic effects on human health and a high impact on environment. The meeting, that will include a wide spectrum of presentation covering the main aspects of cadmium biology as well as its clinical implications, is divided into three main sessions: Cadmium and Environment (Subtopics: Epidemiology; Food Chain) Cadmium and Cell Biology Cadmium, Cancer…