World Conference Calendar

32784 Conferences

Health and Medicinerss


Defining, Architecting and Managing Risk Assessments - Webinar by GlobalCompliancePanel

Defining, Architecting and Managing Risk Assessments - Webinar by GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 08-19-2010 Last Day: 08-19-2010 Deadline for abstracts: 08-18-2010
Risk Assessments are a vital tool in the Risk and Compliance management arsenal. Unless a business knows at any given time what its exposures are, and how they are evolving, the mitigation steps to manage its risks can never be in lockstep with prevailing circumstances or conditions. Concise Risk Assessments are a vital component of any successful Risk based initiative. Intelligent enquiry is an art that is often little understood. How Risk Assessments are created, distributed, collated and analyzed can be the difference between risks detected and managed, and the unwelcomed and often catastrophic risk event. Why should you attend:…
Pharmaceutical Manufacturing Batch Record Review - Webinar by GlobalCompliancePanel

Pharmaceutical Manufacturing Batch Record Review - Webinar by GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 08-18-2010 Last Day: 08-18-2010 Deadline for abstracts: 08-17-2010
The FDA and its European counterpart, EMA, require drug manufacturers to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance. An efficient and effective batch record review process provides pharmaceutical companies with two strategies. First, this effort is key to maintaining control of your firm's manufacturing operations, eliminating any guesswork and aiding in the resolution of atypical occurrences. And, it enables a companys to maintain and demonstrate a compliant posture, a sure way to avoid any quandary with…
Auditing a Process-based System - Webinar by GlobalCompliancePanel

Auditing a Process-based System - Webinar by GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 08-18-2010 Last Day: 08-18-2010 Deadline for abstracts: 08-17-2010
The structure of ISO 9001:2000 provides a focus on the processes that comprise the quality management system (QMS). Also, the general requirements in Clause 4.1 state that the organization must identify all processes of the QMS, their sequence and interaction, and must ensure their effectiveness and the availability of needed resources, and monitor, measure, analyze and improve them. The characteristics defined in Clause 4.1 are a foundation for auditing a process-based system. Additional information used by auditor includes identifying the process owners, inputs and outputs, suppliers and customers, controls and resources of each process. Using this information, the audit team…
Failure Modes and Effects Analysis (FMEA) - An Effective Tool for Medical Device Risk Management - Webinar by GlobalCompliancePanel

Failure Modes and Effects Analysis (FMEA) - An Effective Tool for Medical Device Risk Management - Webinar by GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 08-18-2010 Last Day: 08-18-2010 Deadline for abstracts: 08-17-2010
Most medical device manufacturers use FMEA as a part of their risk management system. Risk Management is required by ISO 13485 and risk analysis by the FDA's Quality System Regulations (QSR) and by of the EU medical device regulations. Using practical examples, this course look at the regulatory and reporting requirements of EN ISO 14971, "Medical devices - application of risk management to medical devices". The FMEA tool is used to provide an understanding of risk management and risk analysis techniques and methodologies, and to develop the skills required to apply these methodologies appropriate to a particular product. Risk management…
How to Survive a DEA Audit - Webinar by GlobalCompliancePanel

How to Survive a DEA Audit - Webinar by GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 08-17-2010 Last Day: 08-17-2010 Deadline for abstracts: 08-16-2010
This training entitled "How to Survive a DEA Audit" will cover all the record-keeping and security requirements that a DEA registrant must comply with when handling controlled substances and regulated chemicals. It covers all elements of what occurs during an unannounced DEA Diversion inspection and the auditing of all controlled substances and regulated chemicals. As a firm handling these products, you will get a better understanding of what is required from a DEA registered manufacturer or distributor. Why Should You Attend: When DEA Diversion personnel conducts an unannounced inspection to perform an audit on a premise that is registered as…
Conduct Your Own Risk Assessments Following ISO Standard 31000/31010 - Webinar by GlobalCompliancePanel

Conduct Your Own Risk Assessments Following ISO Standard 31000/31010 - Webinar by GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 08-17-2010 Last Day: 08-17-2010 Deadline for abstracts: 08-16-2010
For the last decade, there has been an extensive and organized effort by organizations to assess their risks, especially in financial services. The new ISO 31000 and ISO 31010 frameworks provide guidelines in this process that make good sense and build on decades of work by risk professionals Why you should attend: It is essential for any organization to first determine its risk appetite and then to conduct its own self assessment as to its actual risk exposure. The new ISO risk standards provide a straight forward method that is suitable for larger and smaller organizations alike. Aligning your risk…
XII National Congress of Cardiology

XII National Congress of Cardiology

Location: , Bulgaria
Category: Health and Medicine
Start Date: 10-07-2010 Last Day: 10-10-2010
The National Congress of Cardiology is one of the key events on the scientific calendar in Bulgaria bringing together more than 1300 participants from all over the country and eminent foreign specialists. For the first time this year the program of the Congress will include joint session between the European and Bulgarian Societies of Cardiology. Leading international lecturers are invited. For more information: http://cim.bg/index.php/en/view/organizing-XII-national-congress-cardiology/
Medical Devices in the EU: CE Mark and 93/42/EEC Directive

Medical Devices in the EU: CE Mark and 93/42/EEC Directive

Location: , United States
Category: Health and Medicine
Start Date: 09-16-2010 Last Day: 09-16-2010
This webinar will provide valuable assistance and guidance to all regulated companies that are preparing for CE Mark and ensuring compliance to MDD 93/42/EEC. Areas Covered in the seminar: . Identify the steps required to obtain CE Markand meeting compliance expectations. . Understand how to apply and use the Conformity Assessment Procedure. . How to classify your medical device correctly? . Learn how to use the Technical File correctly. . How to apply the Declaration of Conformity and why this is critical for success? . How ISO 13485 fits in with this process as a device company? . Learn and…
How to Manage a Medical Device Recall Efficiently and Effectively

How to Manage a Medical Device Recall Efficiently and Effectively

Location: , United States
Category: Health and Medicine
Start Date: 08-27-2010 Last Day: 08-27-2010
This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDAs involvement. Areas Covered in the seminar: . Create and use a recall operational procedure and what should it contain. . Understand what are effectiveness checks. . What happens in a medical device recall. . Learn why a recall is either a correction or a removal depending on where the action takes place. . Understand why is required for the recall strategy as expected…
Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements in a Relatively Paper-Free Manner

Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements in a Relatively Paper-Free Manner

Location: , United States
Category: Health and Medicine
Start Date: 07-22-2011 Last Day: 07-22-2011
This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process for document control. Areas Covered in the seminar: - QSR and ISO 13485 requirements for document control - Description of typical document control system in use - Streamlined document control process - Paper-free document review - Immediate document distribution.
Recalls of Medical Devices in the US - Medical Device Webinar By ComplianceOnline

Recalls of Medical Devices in the US - Medical Device Webinar By ComplianceOnline

Location: , United States
Category: Health and Medicine
Start Date: 12-02-2010 Last Day: 12-02-2010
In this Medical device recall training learn how to interface with FDA in regards to anticipated recalls, the communication, the response, how to prepare the public information. Areas Covered in the Seminar: - Recent product recall failures. - Analyzing product risks. - CAPA prioritization. - Communicating with FDA. - Deciding on the response. - Preparing the public information. - Notifying the customers. Who Will Benefit: - Medical Device managers - CAPA Managers - Quality Managers - Regulatory Compliance Managers - Product Management - Public Relations personnel - Marketing Management
Principles and Practices of Traceability and Calibration

Principles and Practices of Traceability and Calibration

Location: , United States
Category: Health and Medicine
Start Date: 08-12-2010 Last Day: 08-12-2010
In this Calibration training learn and understand different types of measurements units, measurement constants, calibration and measurement standards as well as principles and practices of traceability. Areas Covered in the Seminar: - Base SI Units. - Derived SI Units. - SI Multipliers and Conversions. - Fundamental Constants. - Common Measurements. - Principles and Practices of Traceability. - Types of Measurement Standards. - Substitution of Calibration Standards. For More Details: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701644?channel=worldconf
Supplier Management for FDA Compliance - Webinar By ComplianceOnline

Supplier Management for FDA Compliance - Webinar By ComplianceOnline

Location: , United States
Category: Health and Medicine
Start Date: 07-12-2012 Last Day: 07-12-2012
This webinar will review in detail the FDA QSR and ISO requirements for supplier evaluation and assessment, and discuss cost effective options for many of the common practices for achieving compliance. Why Should You Attend: Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance with this. Many companies can spend MUCH LESS time and money, and still be in control of their suppliers and in complliance with the regulations. This presentation will review the QSR and ISO requirements for supplier evaluation…
Developing an ethylene oxide (EO) sterilization process for a product with limitations

Developing an ethylene oxide (EO) sterilization process for a product with limitations

Location: , United States
Category: Health and Medicine
Start Date: 09-14-2010 Last Day: 09-14-2010
This EO sterilization training Webinar will discuss how to modify EO sterilization process for complicated medical products which are sensitive to moisture, temperature, vacuum changes. Areas Covered in the Seminar: - How to limit moisture exposure. - Running a low temperature process. - How to address vacuum sensitivity. - Parameter inter-relationships. - How to reduce EO residuals. - Testing outside of the sterilization facility. - Considerations for validation and routine processing. For More Details: http://bit.ly/cVoiXs
Gamma Sterilizer Validation: Method 1 and VDmax25 per ISO 11137

Gamma Sterilizer Validation: Method 1 and VDmax25 per ISO 11137

Location: , United States
Category: Health and Medicine
Start Date: 10-20-2010 Last Day: 10-20-2010
This Sterilization validation training will review the general requirements for validation as described in ISO 11137:2006. Areas Covered in the seminar: - General requirements of ISO 11137:2006, Method 1 and VDmax25, to include (but not limited to): .Pre-validation activities and requirements. .Product bioburden testing and analysis. .Laboratory methods and practices. .Analysis of verification dose results. .Basics components of protocol and final report. For More Details: http://bit.ly/9Gb0dZ
Reducing Ethylene Oxide (EO) Sterilization costs while maintaining regulatory compliance

Reducing Ethylene Oxide (EO) Sterilization costs while maintaining regulatory compliance

Location: , United States
Category: Health and Medicine
Start Date: 07-06-2010 Last Day: 07-06-2010
In this Ethylene Oxide (EO) Sterilization training learn how to evaluate your sterilization process for cost reduction, and will learn how to implement such changes without jeopardizing product safety and regulatory compliance. Areas Covered in the Seminar: -Introduction. -Factors Influencing Lethality and Aeration. -Finding Opportunities for Cycle Optimization. .Negotiate cost reduction .Initial Validation Evaluation Microbiological Method Cycle Parameters Evaluation EO residues dissipation curves Product Evaluation - Cycle/Process Re-engineering .BI Incubation reduction .Parametric Release .PCD/Packaging/Pallet modification .Lethality curve development .Aeration modification - References. Note: Use this Promo Code(101902) to avail Discount of 10% on LIVE Purchase. For More Details: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701616?channel=worldconf
The FDA Tripod - Clinical Trial Regulations, Compliance and GCP in Drug Development

The FDA Tripod - Clinical Trial Regulations, Compliance and GCP in Drug Development

Location: , United States
Category: Health and Medicine
Start Date: 10-05-2010 Last Day: 10-05-2010
This GCP training Webinar will discuss the principals of GCP, the regulations pertaining to it and elements necessary for FDA compliance. Areas Covered in the Seminar: - Discuss the FDAs role in Drug Development. - Principles of GCP. - Activities that are common to most trials. - Summarize FDA GCP regulations. - Recognize how GCP impacts the clinical research process. - Prepare concise documents and provide. - Necessary information for clinical studies compliance. - Maintain ongoing compliance. For More Details: http://bit.ly/9k8s9w
How to Use Foreign Trial Data in Your NDA Approval Process

How to Use Foreign Trial Data in Your NDA Approval Process

Location: , United States
Category: Health and Medicine
Start Date: 09-28-2010 Last Day: 09-28-2010
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. Areas Covered in the Seminar: - Guidances and regulations that govern the FDAs acceptance of foreign trial data as pivotal data for NDA approval. What you can do to ensure compliance. - Design considerations and requirements for foreign trials. - Identify which guidances and regulations govern the FDAs acceptance of foreign trial data as pivotal data for NDA approval;. - Discuss how FDA is implementing…
Vendor selection in clinical trials, assessment activities, audits and log of preferred partners

Vendor selection in clinical trials, assessment activities, audits and log of preferred partners

Location: , United States
Category: Health and Medicine
Start Date: 09-02-2010 Last Day: 09-02-2010
In this Clinical Trial training learn about clinical trial Vendor Assessment, Project Management, Outsourcing, and Trial Design. Areas Covered in the Seminar: - Background of Outsourcing. - The Current Industry Trends. - Advantages vs. Weaknesses of Outsourcing. - Regulatory Expectations. - Suggested Process For Vendor Pre-assessment & Selection (Incl. Documentation). - Managing Vendors. - Performance Assessment for Future Trials (Lessons Learned). - Identifying & Logging Preferred Vendors. For More Details: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701708?channel=worldconf
Outsourcing Clinical Trials in Latin America

Outsourcing Clinical Trials in Latin America

Location: , United States
Category: Health and Medicine
Start Date: 08-12-2010 Last Day: 08-12-2010
This clinical trial training will review some Outsourcing Models that have been used successfully in the Latin American countries where Clinical Research is developed, identifying best practices and opportunities that speed protocol approval in these countries. Areas Covered in the Seminar: - Overview of the Latin American region. - Clinical Trials Activitiy in the Latin American countries. - Outsourcing Capabilities for Clinical Research In Latin America. - Review of available outsourcing providers and their service options. - Opportunitites for Increased efficiency. - Succesful outsourcing models Note: Use this Promo Code(100120) to avail Discount of 10% on LIVE Purchase. For More…

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