World Conference Calendar

32801 Conferences

Health and Medicinerss


Medical Device Reporting Regulations and Violations - Webinar By GlobalCompliancePanel

Medical Device Reporting Regulations and Violations - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 02-16-2011 Last Day: 02-16-2011
Overview: This presentation will review the Medical Device Reporting regulations and common violations leading to Warning Letter filings by FDA. As part of the review, actual Warning Letter and FDA-483 citations of small and large medical device manufacturers will be explored for Medical Device Reporting issues. There is a great deal of concern at FDA over the quality of the information being reported and the timeliness. Some at FDA are concerned that manufacturers have not placed adequate attention to following these regulations, which they consider to be primary indicators of safety issues and therefore very important to the public health.…
Understanding the Technical Requirements of 21 CFR Part 11 - Webinar by GlobalCompliancePanel

Understanding the Technical Requirements of 21 CFR Part 11 - Webinar by GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 02-16-2011 Last Day: 02-16-2011
Overview: Although Part 11 has been around for over a decade, lack of visibility can sometimes render compliance with this regulation an afterthought. Due to serious inefficiencies and non-conformance issues associated with trying to address Part 11 late in the system lifecycle, it is important to give the technical requirements due consideration early in the process. A good understanding of these technical requirements is paramount to avoiding the syndrome of "testing into compliance" later on. Often, the compliance status of a system can be impacted by varying interpretations of the regulation if not properly addressed. This session will provide a…
Electronic Raw Data in Regulated Environments - Definition, Recording and Archiving - Webinar By GlobalCompliancePanel

Electronic Raw Data in Regulated Environments - Definition, Recording and Archiving - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 02-17-2011 Last Day: 02-17-2011
Overview: All regulations have strict requirements for electronic raw data and other e-records. The objective is to ensure accuracy, integrity, authenticity, security and availability of records during the entire life from generation to deletion. While the intent is the same for all regulations only FDA's 21 CFR Part 11 and the EU equivalent Annex 11 have well defined requirements but still leave a lot of room for interpretations. Reference material for easy implementation: * SOP: Recording of GLP and GMP Raw Data. * SOP: Retention and Archiving of Electronic Records * Checklist: FDA Record Retention and Retrieval Areas Covered in…
Water System Biofilm Control and Microbial Monitoring Myths - Webinar By GlobalCompliancePanel

Water System Biofilm Control and Microbial Monitoring Myths - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 02-17-2011 Last Day: 02-17-2011
Overview: It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided? There are many reasons, which will be discussed, but regardless of the causes, we need to be aware of these myths and understand how it really should be done. A number of water system myths will be discussed that are related to microbial control approaches as well as microbial monitoring.…
21 CFR Part 11: Complete Manual For Compliance Success - GlobalCompliancePanel Virtual Seminar - Webinar By GlobalCompliancePanel

21 CFR Part 11: Complete Manual For Compliance Success - GlobalCompliancePanel Virtual Seminar - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 02-17-2011 Last Day: 02-17-2011
Overview: 21 CFR Part 11 is FDA regulation for electronic signatures and electronic records. It started by the Pharma - it is a good regulation for medical and Pharma companies but it is also a good guideline for other industries. Why Should You Attend: FDA inspectors are ever increasing the number of inspections where they include Part 11 as a part of the scope or THE scope of the inspection. The trends and reports are showing that the FDA inspectors are focusing on electronic signatures and electronic records as more and more companies are implementing systems and technologies to support…
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…
OTC Pharma Asia 2011

OTC Pharma Asia 2011

Location: , Singapore
Category: Health and Medicine
Start Date: 02-17-2011 Last Day: 02-18-2011
In 2013, the global OTC pharmaceuticals market is forecast to have a value of US$118.5 billion, an increase of 19.3% since 2008. Pharmacies and drugstores form a leading distribution channel in the global OTC pharmaceuticals market, accounting for 67.3% of the total value. The Asia-Pacific accounts for 38.2% of the global OTC pharmaceutical market. BMI expects the market to post an impressive compound annual growth rate (CAGR) of 7.02% over the next five years, as patients become more responsible for their health. Other drivers include ageing populations, a lower reliance on traditional remedies and the switching of prescription drugs to…
In the Doctor's Office: Recovery Friend or Foe?

In the Doctor's Office: Recovery Friend or Foe?

Location: , United States
Category: Health and Medicine
Start Date: 02-22-2011 Last Day: 02-22-2011
"In the Doctor's Office: Recovery Friend or Foe?" will be presented on Tuesday February 22, 2011, from 7:30 pm to 9:00 pm; by Mark A. Weiner, MD; Internal Medicine and Addiction Medicine; and Jason Schwartz, LMSW; Dawn Farm Clinical Director. It's been said that the doctor's office is a dangerous place for people in recovery from addiction. It's also been said that recovering people are terrible patients. This program will discuss whether these statements are fair and why doctors and other healthcare providers are essential allies for long term recovery. We will describe in detail how recovering people can take…
Complying with HIPAA Security Rules: What's in the rules and how you can most easily prepare for compliance - Webinar By GlobalCompliancePanel

Complying with HIPAA Security Rules: What's in the rules and how you can most easily prepare for compliance - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 02-22-2011 Last Day: 02-22-2011
Overview: If you handle any electronic patient information, don't miss this teleconference on compliance with the HIPAA security regulation. Electronic patient information is everywhere; not only is electronic protected health information in the obvious places such as practice management systems and electronic medical records, but also in less obvious places such as copiers, printers, scanners, cell phones, and portable data devices. Why you should attend: The HIPAA Security Rule, in place and as proposed in amendments going into effect in 2011, calls for all Covered Entities and Business Associates, and their subcontractors, to be in compliance with provisions protecting all…
Using Foreign Trial Data in Your NDA Approval Process - Webinar By GlobalCompliancePanel

Using Foreign Trial Data in Your NDA Approval Process - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 02-22-2011 Last Day: 02-22-2011
Overview: In this NDA Approval Process training Webinar learn the guidance and regulations governing FDAs acceptance of foreign trial data and know how FDA implementing these rule along with design considerations and requirements for foreign trials. Why you should attend: While the law allows 100 percent of pivotal data to come from foreign trials, there have been very few such submissions accepted by FDA - mainly in limited therapeutic areas. Given lower costs and shorter recruiting times, the use of foreign sites is appealing to all drug developers, especially generic and 505(b)(2). Due to shortcomings found during site inspections, lack…
Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - Webinar By GlobalCompliancePanel

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 02-22-2011 Last Day: 02-22-2011
Overview: Recent Consent Decrees have included requirements that the firm develop and implement systems that result in timely and complete investigations of deviations and corrective and preventive actions that address the root cause of deviations. FDA 483 and Warning letter observations identify inadequate investigations and follow-up. This webinar addresses adequate investigation of deviations. Participants will obtain a greater insight into effective investigations and ways to identify the root cause and prevent a similar deviation in the future. The investigation of deviations is clearly a US FDA expectation. The international regulatory expectation for a structured approach to investigations that lead to…
Medical Device Changes and The 510(k) - Webinar By GlobalCompliancePanel

Medical Device Changes and The 510(k) - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 02-23-2011 Last Day: 02-23-2011
Overview: This webinar will examine the broad range of issues to be considered by a company when reviewing 1) A series of minor changes or 2) One major change to an existing product having an existing 510(k), for the need for a new 510(k). Such a review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry) need to do to "toughen" the 510(k) process. A review of recent information from the Agency, including last summer's…
Practical Laboratory Statistics - Webinar by GlobalCompliancePanel

Practical Laboratory Statistics - Webinar by GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 02-23-2011 Last Day: 02-23-2011
Overview: This presentation will attempt to remove the fear of statistics that most people share. We will not spend much time on complex equations. Rather, we will focus on the concepts of statistics, and how you can use these concepts to interpret your laboratory results. Our focus will be on using basic spreadsheet functions to compare data sets generated from many different kinds of test equipment. Why Should You Attend: Most people hate statistics, because they don't understand statistics. If you either generate or review laboratory data, you will want to attend this seminar. We will discuss the basics in…
International Financial Reporting Standards: The Basics - Webinar by GlobalCompliancePanel

International Financial Reporting Standards: The Basics - Webinar by GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 02-23-2011 Last Day: 02-23-2011
Overview: Where business is concerned the world is becoming a smaller place. Trade boundaries are disappearing, and many companies have subsidiaries around the world. Multi-national corporations needed a simpler way to put together their consolidated financial statements. Already Australia, most of Europe, and many other countries have adopted International Financial Reporting Standards. Canadian companies are in the midst of the changeover and the U.S. has begun the process. Are you ready for these changes? Why should you attend: If you are an accounting professional you need to become familiar with exactly what these new International Financial Reporting Standards consist of,…
How to secure GCP compliance in Clinical Trials

How to secure GCP compliance in Clinical Trials

Location: , United States
Category: Health and Medicine
Start Date: 02-23-2011
This GCP compliance in Clinical Trials training aims to provide an overview of the parameters critical in ensuring GCP compliance and in doing this, will translate GCP in a more practical, applied sense. Why Should You Attend: Applying GCP in a real life situation is often subjective, requires experience and training. A Clinical Trial, like any other project is divided in stages with tasks running in parallel or in sequence and affecting one another in a cause and effect relationship. Over the years, findings of inspectors and experiences of monitors have identified clusters of deficiencies in complying with GCP principles,…
Why is CAPA so often cited in medical device inspections - Webinar By GlobalCompliancePanel

Why is CAPA so often cited in medical device inspections - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 02-24-2011 Last Day: 02-24-2011
Overview: This presentation will explore FDA Corrective Action and Preventive Action findings in medical device manufacturer quality systems to determine FDA's concerns. The FDA and ISO 13485 requirements for CAPA will be reviewed to identify how procedures may define a compliant CAPA system. Implementation and maintenance of the CAPA system will be explored. FDA indicates that CAPA systems should be risk-based. The presentation will give an example of how to develop a risk-based CAPA system. Why should you attend: In reviewing FDA Form 483 inspection observation reports and Warning Letters which are published on FDA website, we find CAPA cited…
21 CFR Part 11 - Compliance for Electronic Records and Signatures - Webinar By GlobalCompliancePanel

21 CFR Part 11 - Compliance for Electronic Records and Signatures - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 02-24-2011 Last Day: 02-24-2011
Overview: This webinar details the regulation and how it applies to computerized systems. Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to greatly increase productivity. Areas Covered in the Session: * Which data and systems are subject to Part 11. * What Part 11 means to you, not just what it says in the regulation. * Avoid 483 and Warning…
Cleanroom & HEPA Filter Testing & Certification: An Owners Guide - Webinar by GlobalCompliancePanel

Cleanroom & HEPA Filter Testing & Certification: An Owners Guide - Webinar by GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 02-24-2011 Last Day: 02-24-2011
Overview: This webinar concentrates on identifying and discussing testing and certification requirements associated with cleanrooms. The key benefits of this course are: * In-dept understanding of industry standards, processes, and criteria for testing cleanrooms and HEPA filters * Achieve satisfactory inspections more easily * Higher assurance of new medical product approvals * Minimize nonconformances * Reduce rates of batch rework and rejections * Avoid product recalls Why you should attend: Regulatory agencies expect manufacturers to periodically demonstrate that cleanrooms and controlled environments perform according to their design specifications. In addition, periodic testing confirms the efficacy of maintenance and process controls.…
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…
How to reduce EO residuals in medical devices - Webinar By ComplianceOnline

How to reduce EO residuals in medical devices - Webinar By ComplianceOnline

Location: , United States
Category: Health and Medicine
Start Date: 02-25-2011
This Ethylene Oxide Sterilization Residuals regulation based webinar will provide a practical approach to fulfill requirements of the new ISO EO residual limits revised regulation. Areas Covered in the Seminar: Introduction. Benefits/challenges EO residual limits comparison Factors influencing EO residuals Product/Process Evaluation Initial validation evaluation Product /packaging/pallet configuration Evaluation Process Re-engineering. PCD/packaging/pallet modification Lethality curve development Aeration/Degassing Modification Application of assumed transfer reduction factors References. Who Will Benefit: This seminar is designed for professionals with responsibility for validating or making decisions related to the EO sterilization process Sterilization/Quality Managers Directors or VP Quality or laboratory personnel Chemists Chemistry laboratory Managers…

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