World Conference Calendar

33683 Conferences

Health and Medicinerss


3rd International Conference on Drug Discovery & Therapy

3rd International Conference on Drug Discovery & Therapy

Location: , United Arab Emirates
Category: Health and Medicine
Start Date: 02-07-2011 Last Day: 02-11-2011 Deadline for abstracts: 12-31-2010
The 3rd ICDDT provides a platform for all pharmaceutical scientists, internists and primary care physicians to discuss and learn about the important international breakthrough developments on drug discovery and on new therapeutics. The event envisage 700 leading experts including NOBEL LAUREATES to attend talks on 35 conference tracks and over 300 poster presentations. The commercial exhibition for upto 50 exhibitors will be simultaneously organized.
Analytical Instrument and Equipment Qualification in Quality Laboratories - Webinar By GlobalCompliancePanel

Analytical Instrument and Equipment Qualification in Quality Laboratories - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 02-08-2011 Last Day: 02-08-2011
Overview: The analytical instruments and equipment used in GXP laboratories must be calibrated and qualified for use in regulated testing. This includes quality control labs attached to cGMP facilities, GLP labs supporting animal toxicology studies and GCP labs supporting clinical trials. Additionally, labs supporting EPA studies are also regulated. This seminar will review the regulations that cover each environment and present simple and effective strategies for satisfying the requirements. The impact of USP on analytical instrument qualification will be reviewed and the newest regulation will be presented in a simple and understandable way. The interaction of calibration, qualification, method validation…
Assessing GCP Compliance in Clinical Trial Audits- Risk management and Best practices - Webinar By GlobalCompliancePanel

Assessing GCP Compliance in Clinical Trial Audits- Risk management and Best practices - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 02-08-2011 Last Day: 02-08-2011
Overview: In this Clinical Trial Audits training learn the risk management and best practices of GCP audit by reviewing and analyzing recent GCP audit finding from Clinical Investigators (Sites), Sponsors, and Institutional Review Boards (IRBs). Why you should attend: Quality assurance is defined as a "systematic and independent examination of trial-related activities and documents" that allows an auditor to determine whether or not the clinical trial was conducted according to the regulations and guidance that govern clinical research. This course will provide an overview of auditing skills and techniques and a review of recent GCP audit findings from Clinical Investigators…
Hazard Analysis vs. FMECA – Differences and Commonalities - Webinar By GlobalCompliancePanel

Hazard Analysis vs. FMECA – Differences and Commonalities - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 02-08-2011 Last Day: 02-08-2011
Overview: The terms "Hazard and Risk Analysis" and "Failure Mode, Effects and Criticality Analysis (FMECA)" are often used synonymously. However, there are significant differences in both methodologies and their strengths can be combined to ensure a safe and efficacious system design. The presentation will explain both methodologies and will show ways how these tools can be used to complement each other. Additionally the differences and limitations of both methods will be illustrated and the appropriateness during the different product development phases will be discussed. Areas Covered in the Session: * Hazard analysis techniques * FMECA techniques * Probabilistic approaches *…
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…
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…
Validating Excel and Word Applications Documents - Webinar By GlobalCompliancePanel

Validating Excel and Word Applications Documents - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 02-09-2011 Last Day: 02-09-2011
Overview: Both the U.S. FDA and the EU's MDD require companies to be proactive in reducing risk while increasing user benefits. How does this translate to common software applications programs, e.g., MS-Excel and MS-Word, or similar. How can these be verified and validated? Company quality data must be more "science based". What V&V (verification and validation) planning steps are expected under the CGMPs and other guidance documents for such apps software? How can these consistently be executed? Where does ISO 14971, ICH Q9, and similar risk management systems come in? This webinar will evaluate the climate that has resulted in…
Utilizing Good Requirements as a Foundation for the Effective Validation of PDMA-related Computerized Systems - Webinar By GlobalCompliancePanel

Utilizing Good Requirements as a Foundation for the Effective Validation of PDMA-related Computerized Systems - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 02-09-2011 Last Day: 02-09-2011
Overview: Computerized systems can be a boon to the Sales and Marketing group of an organization that falls within FDA regulatory authority. By automating, tracking, and reporting on thousands of sample product transactions, such systems can provide a powerful mechanism for compliance to the requirements of the Prescription Drug Marketing Act (PDMA), while accomplishing this with a manageable level of effort. However, these systems can get bogged down during implementation due to the need for excessive validation testing and documentation. This, in turn, can lead to lengthy and sometimes fatal delays for roll-out to production. How can such systems be…
Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel

Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 02-09-2011 Last Day: 02-09-2011
Overview: This webinar helps you understand the FDA device regulations related to Excel spreadsheets. These spreadsheets can be automated processes and create electronic records. Both of these aspects are regulated by the FDA, so device manufacturers must understand the regulations and how to apply them. The seminar begins with Excel methods to help ensure the spreadsheet produces the results you want. We explain the built in Validation tools and how to use them to prevent the user from entering incorrect data. We explain the use of Formula Auditing to help ensure the calculations are performed correctly. Lastly, we explain the…
Operational Risk Management: Ensuring Safety for Food Systems - Webinar By GlobalCompliancePanel

Operational Risk Management: Ensuring Safety for Food Systems - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 02-10-2011 Last Day: 02-10-2011
Overview: With today's movement into more and more serious controls over food safety and security, the liabilities associated with recalls and deaths are creating new approaches to determine and reduce the likelihood of risks associated with contaminated foods. Risk assessment involves determining where and what types of risks are involved throughout any food process, assigning quantitative values to those risks, measuring the processes based on risk factors and ranking risk areas for purposes of preventive and corrective actions. Risk management requires no more or less management skill levels than any production, quality or purchasing operation - risk management simply requires…
Internal Audits: Maintaining your Quality Systems at the Ready - Webinar By GlobalCompliancePanel

Internal Audits: Maintaining your Quality Systems at the Ready - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 02-10-2011 Last Day: 02-10-2011
Overview: While not captured in most audit reports, one of the biggest mistakes an organization can make is to have insufficient self audits. Internal audits are a core component of the Quality Assurance and Food Safety program. Ensuring the team representatives are trained and calibrated is a critical aspect of the program. An untrained team will miss important audit items, compromising the confidence in the company’s ability to assess and improve its own systems. Why you should attend: Maintenance is often found to present the greatest area of opportunity for improvement in the food safety chain. Lack of control of…
Webinar on Medical Device Tracking

Webinar on Medical Device Tracking

Location: , United States
Category: Health and Medicine
Start Date: 02-10-2011
Understanding of latest FDA guidance requirements and expectations related to medical device tracking and what are the new changes. Section 519(e), as revised by FDAMA, states the agency may require tracking for a class II or class III devices: (A) the failure of which would be reasonably likely to have serious adverse health consequences; or (B) which is intended to be implanted in the human body for more than one year; or (C) which is a life sustaining or life supporting device used outside a device user facility. This medical device tracking webinar training will address the latest FDA guidance…
Food Safety Management Systems - ISO 22000:2005 - Webinar By GlobalCompliancePanel

Food Safety Management Systems - ISO 22000:2005 - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 02-10-2011 Last Day: 02-10-2011
Overview: This presentation will assist organizations within the food chain to understand the requirements to meet the international standard for Food Safety Management. Areas Covered in the Session: The following areas will be addressed: * Key terms and definitions * General Requirements * Documentation * Management Responsibility * Resource Management * Planning and Realization of Safe Products – flow diagrams, process steps and control measures * Hazard Assessment - Control Measures * Design and Redesign of HACCP Plan – Critical control points * Verification * Corrections and Corrective Actions * Handling of Potentially Unsafe Products * Recalls * Verification, Validation…
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…
CE Marking: Obtaining and Maintaining EU Compliance Under the Medical Device Directive - Webinar By ComplianceOnline

CE Marking: Obtaining and Maintaining EU Compliance Under the Medical Device Directive - Webinar By ComplianceOnline

Location: , United States
Category: Health and Medicine
Start Date: 02-11-2011
This CE marking training will discuss the recent changes to MDD (Medical Device Directive), how to identify non compliance areas, contents of the technical file and essential requirements document and how to select notified bodies for MD compliance. Areas Covered in the Seminar: Device classification distinctions, and what that means to you in terms of compliance burden. Technical File contents and organization. Review and selection of your notified body. How to show compliance with the Essential Requirements. Changes to MDD and their implications. What is expected for clinical data. Who Will Benefit: This webinar will provide valuable assistance to all…
The Intersection of Domestic Violence and Substance Abuse

The Intersection of Domestic Violence and Substance Abuse

Location: , United States
Category: Health and Medicine
Start Date: 02-15-2011 Last Day: 02-15-2011
"The Intersection of Domestic Violence and Substance Abuse" will be presented on Tuesday February 15, 2011, from 7:30 pm to 9:00 pm; by Barbara Niess May, MPH, MSW; Executive Director, SafeHouse Center; and David J.H. Garvin, LMSW; Director, Alternatives to Domestic Aggression, Catholic Social Services of Washtenaw County. Domestic violence offender and survivor alcohol and other drug use/abuse will be central to this discussion. The audience will be provided with a primmer regarding batterer tactics, strategies, and core beliefs which hold the batterer accountable for his abusive behaviors while maintaining and promoting survivor safety. The program will help participants to…
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…
Controlled Substances and the Pharmacist - Webinar By GlobalCompliancePanel

Controlled Substances and the Pharmacist - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 02-15-2011 Last Day: 02-15-2011
Overview: The public media has been reporting the abuse of narcotic drugs prescribed for pain management with its focus on the legitimacy of prescriptions and the dispensing by a pharmacist. Both federal and state regulations have placed the responsibilities on the physician who wrote the prescription and the pharmacist who filled the prescription. Today's pharmacists will need to familiarize themselves with the stringent laws and regulations enforced by the Drug Enforcement Administration (DEA) through their Office of Diversion Control (Diversion). Since the focus of any DEA investigation is the legitimacy of a prescription, the initial target is the pharmacist who…
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),…
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…

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