World Conference Calendar

35139 Conferences

Health and Medicinerss


How Due Diligence in Accurate Adverse Event Reporting is the Key to a clean FDA Audit

How Due Diligence in Accurate Adverse Event Reporting is the Key to a clean FDA Audit

Location: , United States
Category: Health and Medicine
Start Date: 08-19-2011 Last Day: 08-19-2011
Why Should You Attend: Presently, there is an increase in real-time FDA Audits of trials and it seems that no one is well prepared. It is the obligation of the major players in the drug development process (the Investigator and the study Sponsor) to be sure studies are carried out correctly so that errors and mistakes are found and corrected. The most important subject safety error is to incorrectly observing and reporting Adverse Events even SAEs. AE’s are one of the key ways the Clinical Investigator has of monitoring the safety of subjects or patients in her/his charge. In this…
Sterilization Options for Challenging Products

Sterilization Options for Challenging Products

Location: , United States
Category: Health and Medicine
Start Date: 08-18-2011 Last Day: 08-18-2011
Why Should You Attend: Medical products are more complicated and have greater challenges for sterilization process than ever before. These products might include tissue-based products, combination products, devices with drug coatings, devices with batteries or equipped with integrated software, circuits or computer chips. Each of these present their own challenges for sterilization starting with selecting a compatible process to developing the validation strategy and meeting the regulatory requirements for ensuring that the sterilization process is adequate for the medical product. Making a mistake can be costly not only in immediate costs but also in project delays and potentially in regulatory…
Understanding the Difference: HIPAA Security Compliance Assessment v. HIPAA Security Risk Analysis

Understanding the Difference: HIPAA Security Compliance Assessment v. HIPAA Security Risk Analysis

Location: , United States
Category: Health and Medicine
Start Date: 08-18-2011 Last Day: 08-18-2011
Why Should You Attend: Complying with the HIPAA Security Final Rule itself and as amended by the Health Information Technology for Economic and Clinical Health (HITECH) Act, which was enacted as part of the American Recovery and Reinvestment Act (ARRA) of 2009 involves many steps and considerations. What's most important is starting on the right foot. In this webinar, we focus on the two evaluations you must complete, by law. Both are Required by the HIPAA Security Final Rule. A thorough HIPAA Security Compliance Evaluation broadly covers all aspects of the law including all 22 Standards and 53 Implementation Specifications…
China: Compliance Processes for Life Science Products

China: Compliance Processes for Life Science Products

Location: , United States
Category: Health and Medicine
Start Date: 08-17-2011 Last Day: 08-17-2011
Why Should You Attend: China has been improving its regulatory regime governing the food and pharmaceutical industry in recent years. In 2010, by promulgating the amended GMP and amending GLP, GCP, GSP and other regulations, China will further align the country with international standards of practice. For manufacturers and distributors of drugs and medical devices in China, it is important to pay close attention to the pace at which SFDA implements these changes and to make changes to their standard operating procedures when necessary to ensure compliance with the evolving regime. This 6-hr course specifically focuses on the overall regulatory…
ISO 13485 and medical device quality systems - practical strategies for planning, implementation and beyond

ISO 13485 and medical device quality systems - practical strategies for planning, implementation and beyond

Location: , United States
Category: Health and Medicine
Start Date: 08-17-2011 Last Day: 08-17-2011
Why Should You Attend: Whether you are experienced with your medical device quality system or are taking on the responsibility for the first time, it is a benefit to learn proven strategies from quality professionals with hands-on experience. This session will discuss how to design and maintain your quality system to meet requirements to target the US, Canada and EU. We will also cover documentation and implementation planning, strategies for selection and interface with certification bodies and auditors, and getting value for your investment. You will learn practical tips to help with post registration maintenance, ongoing or expanded certification, and…
How to Survive a DEA Inspection Series: Only Manufacturers and Distributors - Webinar By GlobalCompliancePane

How to Survive a DEA Inspection Series: Only Manufacturers and Distributors - Webinar By GlobalCompliancePane

Location: , United States
Category: Health and Medicine
Start Date: 08-17-2011 Last Day: 08-17-2011
Why should you attend: When DEA Diversion personnel conducts unannounced inspection to perform an audit on a premise that is registered as a Manufacturer or Distributor, they generally do not inform the DEA registrant on what steps will be taken during the inspection. In some cases, the registrant is not aware of what information they will need to provide until DEA ask the registrant. In so many cases, the lack of record-keeping and security requirements will lead to some type of actions from an administrative violations to a civil action that may result in the firm paying thousands of dollars…
21 CFR Part 11 and Annex 11; What you Need to Know to Pass the New Regulatory Audits - Webinar By GlobalCompliancePanel

21 CFR Part 11 and Annex 11; What you Need to Know to Pass the New Regulatory Audits - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 08-16-2011 Last Day: 08-16-2011
Learn exactly what is needed to be compliant for all three primary compliance 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 the new European equivalent Annex 11. It gets 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 the regulations? What the regulations mean, not just what they say. Avoid 483 and Warning Letters. Examine the regulatory requirements for the three primary areas of Part 11…
International Conference And Exhibition On Cancer Science & Therapy 2011

International Conference And Exhibition On Cancer Science & Therapy 2011

Location: , United States
Category: Health and Medicine
Start Date: 08-15-2011 Last Day: 08-17-2011 Deadline for abstracts: 05-16-2011
OMICS Group invites all the participants across the globe to attend International Conference & Exhibition on Cancer Science & Therapy during 15-17 August 2011 Las Vegas, USA. Cancer Science-2011 is a remarkable event which brings together a unique and International mix of large and medium pharmaceutical, biotech and diagnostics companies, leading universities and clinical research institutions making the Congress a perfect platform to share experience, foster collaborations across industry and academia, and evaluate emerging technologies across the globe. The conference highlights the following topics: • Cancer Cell Biology • Cancer Immunology • Diagnostic and Prognostic Cancer Biomarkers • Carcinogenesis &…
Design History File (DHF) Device Master Record (DMR) Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained - Webinar By GlobalCompliancePanel

Design History File (DHF) Device Master Record (DMR) Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 08-15-2011 Last Day: 08-15-2011
Why you should attend: The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF). Do you know what information should reside in a DHF, a DMR and a DHR? This Webinar will define, explain and clarify the different records. Are you maintaining adequate DHF, DMR, DHR, and TF records? Do you know what data and information need to reside and where does it reside? Are your records easily…
Clinical Project Management - Webinar By ComplianceOnline

Clinical Project Management - Webinar By ComplianceOnline

Location: , United States
Category: Health and Medicine
Start Date: 08-12-2011 Last Day: 08-12-2011
Why Should You Attend: Clinical trials make up more than 90% of time, expense and logistical challenges for a drug development project. Clinical trials involve personnel of diverse expertise and different roles at various times in the development pathway. Multiple aspects of most clinical projects are spread nation-wide and more often internationally. Hence these projects present unique challenges and require distinctive skills for successful project execution. This training course will provide valuable tools and practical tips for initiating, managing, and presenting data from clinical projects to both to new professionals in the field and experienced hands. If you are aspiring…
Construct and Manage the Technical File and Design Dossier

Construct and Manage the Technical File and Design Dossier

Location: , United States
Category: Health and Medicine
Start Date: 08-11-2011 Last Day: 08-11-2011
This Webinar will provide a substantive overview and outline differences between the Technical File and Design Dossier for those device firms dealing with the global regulatory landscape. It is assumed that participants and customers have a prior CE Mark and Medical Device Directive background. The Technical File is a comprehensive collection of information and documents that details everything about your medical device. Understanding how to assemble this information and present the information properly is essential. If you manufacture a Class I device, a less complex CE Marking Technical File may be required. In the case of Class IIa, IIb and…
Practical Laboratory Statistics

Practical Laboratory Statistics

Location: , United States
Category: Health and Medicine
Start Date: 08-11-2011 Last Day: 08-11-2011
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 a…
How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare - Webinar By GlobalCompliancePanel

How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 08-10-2011 Last Day: 08-10-2011
This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. This session will discuss what the FDA tells their inspectors, and how they train them, including a detailed analysis of the CAPA training. Also contained in this session will be a section-by-section summary of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document in your preparation. Why you should attend: What should I expect…
How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant?

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant?

Location: , United States
Category: Health and Medicine
Start Date: 08-09-2011 Last Day: 08-09-2011
In this GCP compliance webinar learn how to prevent and handle protocol deviations and violations Areas Covered in the Seminar: The Primacy of the study Protocol. What are Protocol “Deviation” and other terms / categories. The many cause of protocol deviations. The Regulatory requirements for handling protocol deviations and violations. The importance of documentation of protocol deviations as well as violations. How to define and handle instances of PNF. What is the reason different IRBs define deviations and violations differently. What is the basis of the difference between a “Deviation” and a “Violation”. Who Will Benefit: This Webinar will provide…
BIT's 2nd Annual International Conference of Medichem-2011  (ICM2011)

BIT's 2nd Annual International Conference of Medichem-2011 (ICM2011)

Location: , China
Category: Health and Medicine
Start Date: 08-09-2011 Last Day: 08-11-2011
On behalf of the organizing committee, I cordially welcome you to join the "BIT 2nd Annual International Conference of Medichem-2011 (ICM-2011) ", which will be held during August 9-11, 2011 in Beijing, China, with a theme of "Master Drug Discovery Chemistry". Medicinal Chemistry as a major tool in delivery of drug candidates plays an important role in drug discovery and development. With ever increasing demand on the MediChem R & D outsourcing to India and China, tremendous number of talented chemists is particularly interested in grasping the current themes in modern medicinal chemistry. Therefore, the aim of ICM is to…
Creation and management of a Controlled Document System for a Life Sciences manufacturing plant utilizing the principles of Lean Documents and Lean Configuration  - Webinar By GlobalCompliancePanel

Creation and management of a Controlled Document System for a Life Sciences manufacturing plant utilizing the principles of Lean Documents and Lean Configuration - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 08-09-2011 Last Day: 08-09-2011 Deadline for abstracts: 08-08-2011
Overview: Controlled documents are one of the foundational building blocks of a Quality Management System (QMS) for regulated industries. Too often, controlled documents are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed. This webinar applies the Theory of Lean Documents and the corresponding Theory of Lean Configuration to this key part of a QMS. Why you should attend: Do you find yourself constantly struggling to create, manage, and maintain all of the information found in controlled documents - which is often redundant, repetitive, and chained together in a cumbersome way? Do you…
Verification vs. Validation in Regulated Industries

Verification vs. Validation in Regulated Industries

Location: , United States
Category: Health and Medicine
Start Date: 08-09-2011 Last Day: 08-09-2011
Attend this webinar to understand the differences and benefits of verification and validation. Learn about the risks and complications involved with the application of sound verification and validation principles. Why Should You Attend: The meanings and regulatory requirements of the terms "verification" and "validation" are often confusing to engineers and even some regulatory professionals. FDA regulations as well as European standards such as ISO 13485:2003 require both verification & validation documentation throughout these regulations and standards.The terms apply to design control, process control and others. Verification and validation also appear in the "essential requirements" in MDD 93/42/EEC needed for CE…
Residual Risk and Risk based Verification

Residual Risk and Risk based Verification

Location: , United States
Category: Health and Medicine
Start Date: 08-09-2011 Last Day: 08-09-2011
Learn how define the residual risk of your device and how to streamline the verification process by employing a risk based approach. Adjusting the verification process to account for the criticality of the verified items can drastically reduce the overall cost and time for verification activities. By implementing a risk based verification approach activities at the end of the device development can be streamlines and the time to market can be shortened without compromising the safety or effectiveness of the medical device. Areas Covered in the Session Residual risk identification and declaration Risk based verification techniques Objective base verification planning…
Global HTA and CER Forum 2011

Global HTA and CER Forum 2011

Location: , United States
Category: Health and Medicine
Start Date: 08-08-2011 Last Day: 08-31-2011
The Web's Largest Online HTA and CER Conference Developing optimum strategies for understanding health technology assessment requirements, demonstrating comparative effectiveness and speeding reimbursement in the pharmaceutical industry
BIT's 1st Annual World Congress of Molecular & Cell Biology  (CMCB2011)

BIT's 1st Annual World Congress of Molecular & Cell Biology (CMCB2011)

Location: , China
Category: Health and Medicine
Start Date: 08-06-2011 Last Day: 08-08-2011
BIT’s 1st Annual World Congress of Molecular & Cell Biology (CMCB-2011) will be held in Beijing, China during August 6-8, 2011, 2011. CMCB-2011 is dedicated to the dissemination of advanced knowledge in all areas of cellular and molecular biology, certain aspects of biochemistry, biophysics and biotechnology. It is designed to provide a strong platform for professionals from both academic and industrial sections to make experience exchanges around the world. Since Cell and molecular Biology have made tremendous strides over time, we aim to bring together biochemists, molecular biologists, cell and developmental biologists and other professionals who are active in the…

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