World Conference Calendar

33622 Conferences

Health and Medicinerss


Tougher U.S. FDA cGMP Compliance Audits - When You're Not Ready - Webinar by GlobalCompliancePanel

Tougher U.S. FDA cGMP Compliance Audits - When You're Not Ready - Webinar by GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 03-09-2011 Last Day: 03-09-2011
Overview: There is an on-going major shift in the emphasis of U.S. FDA cGMP compliance audits. These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success. The Agency has come under increasing negative publicity due to multiple drug recalls and pulling of product off the market, importation of tainted foods, lead based paint in toys, and recent public concern over insufficient oversite of new product introductions (and grandfathered product) by means of the 510(k) system. Business continues to "shoot itself in the foot", including once highly respected companies. All this affects the Agency's…
BIT's 3rd Annual World Vaccine Congress  (wcv2011)

BIT's 3rd Annual World Vaccine Congress (wcv2011)

Location: , China
Category: Health and Medicine
Start Date: 03-23-2011 Last Day: 03-25-2011
Dear Friends and Colleges, BIT Life Sciences is proud to announce that the 3rd Annual World Vaccine Congress (WCV-2011) will be held in Beijing China with the theme “The Future of Global Vaccines.” WCV-2011 will be the largest meeting devoted exclusively to research of vaccines associated with infectious and non-infectious diseases in China. The meeting will gather experts from all over the world to discuss exciting breakthroughs and to share information on emerging vaccine technologies. To protect the world from health threats, we need a safe and effective supply of vaccines urgently. BIT Life Sciences’ Annual World Congress of Vaccine…
BIT's 3rd Annual International Congress of Antibody  (ica2011)

BIT's 3rd Annual International Congress of Antibody (ica2011)

Location: , China
Category: Health and Medicine
Start Date: 03-23-2011 Last Day: 03-25-2011
Dear Friends and Colleagues, BIT Life Sciences is proud to announce that the 3rd Annual International Congress of Antibodies (ICA-2011) will be held March 23-25, 2011 in Beijing, China with the theme “Discovery, Partnering to Market.” On behalf of the organizing committee, I cordially invite you to attend our conference. Initiated by BIT Life Sciences in 2008, ICA offers a unique meeting place for professionals from all over the world to share scientific information, seek research collaborations, foster new business opportunities, and discuss how to prevent and treat disease. In 2010, ICA was held with the 2nd Annual World Vaccine…
Quality Management System and Risk Management for Medical Devices

Quality Management System and Risk Management for Medical Devices

Location: , United States
Category: Health and Medicine
Start Date: 02-28-2011 Last Day: 03-01-2011
Course Description: Medical device manufacturers implement a Quality Management System (QMS) as part of the regulatory requirements. For products marketed in the EU and Canada, manufacturers use ISO 13485. For products marketed in the US, the requirement is FDA QSR. Both systems stem from ISO 9001 concepts. A critical element of medical device quality is Risk Management. The basic standard is ISO 14971. This 2 days ComplianceOnline seminar covers the essential elements of a medical device quality management system involved in creating an effective Risk Management system. Using ISO 13485 as a model, the seminar covers the QMS essentials that…
Integrating a Quality Management System and Risk Management for Medical Devices

Integrating a Quality Management System and Risk Management for Medical Devices

Location: , United States
Category: Health and Medicine
Start Date: 02-24-2011 Last Day: 02-25-2011
Course Description: Medical device manufacturers implement a Quality Management System (QMS) as part of the regulatory requirements. For products marketed in the EU and Canada, manufacturers use ISO 13485. For products marketed in the US, the requirement is FDA QSR. Both systems stem from ISO 9001 concepts. A critical element of medical device quality is Risk Management. The basic standard is ISO 14971. This 2 days ComplianceOnline seminar covers the essential elements of a medical device quality management system involved in creating an effective Risk Management system. Using ISO 13485 as a model, the seminar covers the QMS essentials that…
Design Control for Medical Industry

Design Control for Medical Industry

Location: , United States
Category: Health and Medicine
Start Date: 03-08-2011
Why Should You Attend: FDA expectations for compliance with the Design Control requirements according to the CFR 820.30 have increased significantly in recent years. A well established design control process can not only make the devices compliant but also can eliminate the unnecessary wastes from the system. This course will cover the essential areas of the Design Control and the methods to effectively improve / implement them within the existing or new product development process. The training will also cover the proven methods for effectively driving the entire process. Learning Objectives: Understanding the CFR requirements. Getting ready for FDA inspection.…
Software Verification and Validation Planning and Execution

Software Verification and Validation Planning and Execution

Location: , United States
Category: Health and Medicine
Start Date: 07-12-2011 Last Day: 07-12-2011
In this Software Verification and Validation training Understand and recognize the most common software V&V failings and their fixes. Learn how to develop and use a repeatable software V&V template for all software validation projects. Why Should You Attend: Software and related hardware design, development, verification and validation is difficult to manage, document and control. Where as Software design and development is under increased scrutiny by the new "tougher" U.S. FDA. This is with good reason. Product, production / test equipment, and even the QMS are increasingly software / firmware driven. This presentation focuses on the verification and validation planning…
Don't RISK to ignore RISKS. Understanding ISO 14971

Don't RISK to ignore RISKS. Understanding ISO 14971

Location: , United States
Category: Health and Medicine
Start Date: 02-15-2011
Why Should You Attend: Medical Device Companies are using different tools to identify and manage the risks but sometimes companies lack the over all process to connect the dots. This gap has resulted in several field failures and significant recalls of the products due to inappropriate prioritization of risks involved. ISO 14971 provides a comprehensive model to not only identify the risk, but also to prioritize and mitigate the risks to as low as reasonably possible. The scope includes the entire product realization process including the afterlife disposal of the devices. This 3.5 hr webinar will discuss the key elements…
Risk-Based Verification and Validation Planning to Meet U.S. FDA, ICH Q9 and ISO 14971

Risk-Based Verification and Validation Planning to Meet U.S. FDA, ICH Q9 and ISO 14971

Location: , United States
Category: Health and Medicine
Start Date: 02-08-2011
In this V & V planning training Webinar learn to create a Master Validation plan, evaluate its elements against ISO 14971, ICH Q9 for hazard analysis and Risk management. How to employ DQs, IQs, OQs and PQs. Why Should You Attend: FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based V&V planning. Why do companies need a Master Validation Plan? What are the must have elements from ISO 14971 and ICH Q9 for hazard analysis and product risk management? How can these be integrated into…
Presenting the real GCP handbook

Presenting the real GCP handbook

Location: , United States
Category: Health and Medicine
Start Date: 03-31-2011
Get a complete understanding of GCP through a comprehensive analysis of GCP official text - NOTE FOR GUIDANCE ON GOOD CLINICAL PRACTICE, CPMP/ICH/135/95, July 2002. Why Should You Attend: When conducting a Clinical Trial, GCP is the only recognized code of practice and needs to be followed meticulously. Following patient enrollment, knowledge of GCP is taken for granted by auditors and inspectors alike. Study Sponsors, include GCP training as part of investigator meetings, prestudy and initiation visits and their own employee training programs. A number of third party organizations offer relevant seminars. Training certificates are being issued to prove GCP…
Responsibilities of a Clinical Research Coordinator managing clinical trial

Responsibilities of a Clinical Research Coordinator managing clinical trial

Location: , United States
Category: Health and Medicine
Start Date: 03-01-2011
As a CRC Understand how to successfully execute the responsibilities for clinical trial and maintain integrity of trial. Why Should You Attend: With the growth of the Biotechnology industry, Clinical Research Coordinator (CRC) positions are expected to increase by 2016. The CRC is the heart and soul of the trial thus it is important to be well organized and well informed about the role and responsibilities. This presentation will help with preparing a coordinator with how to successfully select a trial, what to do after you select trails, once trials are selected how to get prepared before the trial start,…
Last changes in Canadian ethics regulations for clinical trial

Last changes in Canadian ethics regulations for clinical trial

Location: , United States
Category: Health and Medicine
Start Date: 07-12-2011 Last Day: 07-12-2011
Learn about last changes in Canadian ethics regulations, understand how to apply the change in the day-to-day work. Why Should You Attend: With the growth of the Pharmaceutical and Biotechnology industry, ethics regulations become more and more complicated. To protect safety and liberty of clinical trial participants some of the ethics regulations changed in the last years. Also, concerns for patient's confidentiality and privacy brought some other changes in the regulations. This webinar presentation will help you to understand the last changes that occurred in Canadian ethics regulations. It will clarify for sites and sponsors how to ease the ethics…
Responsibilities of a Principal Investigator in Clinical Trials

Responsibilities of a Principal Investigator in Clinical Trials

Location: , United States
Category: Health and Medicine
Start Date: 02-15-2011
Discussion on role and responsibilities of clinical trial investigator and the legal and regulatory requirements to follow for Good Clinical Practices (GCP). Why Should You Attend: When the PI signs the FDA form 1572 (for IND studies) or the "Statement of the Investigator (for IDE studies), she / he is signing a legally binding document committing themselves to follow all of the appropriate regulations. The responsibilities are clearly described / outlined in The ICH GCP Guidelines of E6 (4.1 to 4.13). Additionally, named in the 1572 is 21 CFR 50 (Protection of Human Subjects), 21 CFR 56 (Institutional Review Boards),…
Compliance with The European Medicines Agency reflection paper

Compliance with The European Medicines Agency reflection paper

Location: , United States
Category: Health and Medicine
Start Date: 02-08-2011
This webinar will help you understand the compliance requirements concerning EMA reflection paper on e-source data (EMA/INS/GCP/454280/2010). Why Should You Attend: The European Medicines Agency (EMA) has adopted a reflection paper on GCP inspectors’ expectations for e-source data (EMA/INS/GCP/454280/2010). The paper, which came into effect on 1 August 2010, outlines the current opinion of the EU GCP Inspectors Working Group on the use of electronic data capture in clinical trials and on related inspections. This reflection paper is very consistent with the FDA‘s most recent guidance on computerized systems. The 12 principles described in the Clinical Data Interchange Standards Consortium…
How to prepare for Increased OSHA penalties in 2011

How to prepare for Increased OSHA penalties in 2011

Location: , United States
Category: Health and Medicine
Start Date: 02-28-2011
Why Should You Attend: The Obama administration has identified OSHA compliance as a top enforcement priority and has promised to aggressively monitor businesses for compliance with workplace safety requirements. Employers and their counsel should prepare now for increased OSHA inspections, closer scrutiny of injury recordkeeping and reporting, a stronger focus on investigations of employee whistleblower claims, and tougher negotiations with OSHA regarding penalties and citations. We will outline strategies for preparing and participating in an inspection, responding to citations, and negotiating penalties with OSHA. Questions to be discussed: What should employers expect from the recent increase in OSHA enforcement? What…
Hazardous Waste Regulation: 10 Major Differences Between Federal RCRA and California Hazardous Waste Regulations

Hazardous Waste Regulation: 10 Major Differences Between Federal RCRA and California Hazardous Waste Regulations

Location: , United States
Category: Health and Medicine
Start Date: 03-30-2011
Why Should You Attend: California has unique hazardous waste regulations that include, but substantially exceed requirements of the federal Resource Conservation and Recovery Act (RCRA) regulations generally in effect in other states. It is also hard to navigate California’s hazardous waste requirements because of the dramatic differences in substantive requirements, enforced by pervasive local city and county agencies deputized as Certified Unified Program Agencies (CUPAs) and result in surprising violations and onerous penalties. These national and international corporations did not know they were doing anything wrong because, under RCRA, most of these offenses would not be violations, and rarely are…
Techniques of Hazard Recognition

Techniques of Hazard Recognition

Location: , United States
Category: Health and Medicine
Start Date: 02-17-2011
Learn the multi layered approach to hazard recognition and the step in establishing hazard recognition system. The key techniques that can be used on filed by the employees. Why Should You Attend: There are numerous techniques used by employers to help identify hazards. Which ones do you use? Which are best suited for your operation? This presentation is intended to help attendees increase their overall level of safety awareness and be more cognizant of the hazards that surround them in the workplace. The presentation focuses on five simple and quick techniques which can be taught to and used by field…
International Stem Cell Corporation Announces Company Update Conference Call

International Stem Cell Corporation Announces Company Update Conference Call

Location: , United States
Category: Health and Medicine
Start Date: 01-19-2011
International Stem Cell Corporation (OTCBB:ISCO), www.internationalstemcell.com, announced today that its Chairman, Kenneth Aldrich and the CEO of its Lifeline Skin Care subsidiary, Ruslan Semechkin, PhD, will present a Webinar discussion of the State of the Company and its plans for its Skin Care subsidiary on Wednesday, January 19, 2011 at 10:00 a.m. PST. In announcing the event, Mr. Aldrich stressed that its purpose is not to announce any new programs or financial results, but to attempt to provide an overview of events during the past year and offer shareholders a perspective on what to expect in the coming year. The…
Introduction to Investment Risk - Credit, Market and Portfolio - Webinar by GlobalCompliancePanel

Introduction to Investment Risk - Credit, Market and Portfolio - Webinar by GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 02-15-2011 Last Day: 02-15-2011
Overview: This three hour overview of investment risk will provide the fundamentals to market, portfolio, and credit risk management that all investors, and those in financial services need to comprehend. Regardless of job titles, investment risk management is a shared responsibility by a wide range of managers. Compared to accounting, risk is an immature discipline with a variety of risk frameworks competing to dominate. Based on the new Wiley and Sons book, Essentials of Risk Management, (January 2010), this webinar is designed to provide an introduction to an area and discipline that is changing rapidly, especially in the light of…
Clinical Trial auditing - Identifying risks and building a more compliant and successful trial

Clinical Trial auditing - Identifying risks and building a more compliant and successful trial

Location: , United States
Category: Health and Medicine
Start Date: 02-10-2011
Learn how to successfully pass a clinical trial audit, how to prepare for it, where and how to identify the non compliance. Know FDA inspection strategy to identify areas of common deficiency. This clinical trial audit webinar will help with preparing the site and the study team with how to successfully prepare for an audit, how to identify risk of noncompliance, what to do before, during and after an audit. The session will give you practical solutions to get the best results from an audit and the opportunity to grow the image of your team and/or your site. This session…

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