World Conference Calendar

31708 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:…
Best Practices in Complaint Management - Webinar by GlobalCompliancePanel

Best Practices in Complaint Management - 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
Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s. This session will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action, as well as the ISO-specific implications. This session will discuss the best way to document customer feedback, what constitutes a…
Important Sterilization Information for Product Developers - Webinar by GlobalCompliancePanel

Important Sterilization Information for Product Developers - 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
Product developers have the responsibility of the development of medical devices or healthcare products that will be sterilized; however they may not have an adequate understanding of the sterilization processes and its impact to the functionality of the product and its package. This presentation will provide information that can be used by R&D Engineers and Product Developers to aid them in the selection of materials, design characteristics and appropriate packaging by providing them with a basic knowledge of what is involved in the process of sterilization. It will also provide guidance on how the sterilization process can be changed to…
Change Control and Logging in the PCI environment - Webinar by GlobalCompliancePanel

Change Control and Logging in the PCI environment - Webinar by GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 08-19-2010 Last Day: 08-19-2010 Deadline for abstracts: 08-19-2010
Change control in IT environments has been a focus for a decade or so, especially for application changes. In this webinar you will learn: The components of a strong change management program, including specifics on configuration management, system hardening, and compliance review. In addition, the types of logging and monitoring required by the PCI DSS will be discussed which will enable confidence in approaches and tools that will meet the intent of the requirement and establish security. Why Should You Attend:Configuration changes are also important to document and test and standards like the PCI DSS have brought this topic to…
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: 08-19-2010 Last Day: 08-19-2010
This CE technical files based training Webinar will discuss the difference between Technical File and Design Dossier and explain how to create them and the best practices. Areas Covered in the Seminar: - Learn the differences between the Tech File and Dossier and why the construction phase is so important. - Compile the EU Technical File or Design Dossier and ensure - Format and Content expectations are addressed appropriately. - Understand why Design Dossier is viewed as a subset of the Tech Documentation with emphasis on design. - Determine exactly which materials need to be assembled. - NB must examine…
Fundamentals of FDAs Clinical Trial Audits  A Must- Know for Audit preparation

Fundamentals of FDAs Clinical Trial Audits A Must- Know for Audit preparation

Location: , United States
Category: Health and Medicine
Start Date: 08-24-2010 Last Day: 08-24-2010
This Clinical Trial Audits webinar will provide help both CRAs and sites utilize quality improvement methods and effectively prepare for upcoming GCP audits. Areas Covered in the Seminar: - Differentiation of work of an auditor vs. Clinical Research Associate. - Most common audit deficiencies noted among sites and sponsors. - Techniques used in audit planning. - Factors involved in selection process. - Overview of GCP regulations and FDA guidelines used for audits. - Audit documentation and proper follow-up procedures. Overview of Preparing for Audit. For More Details: http://bit.ly/9y3KRz
A Guide for Compliance with Document Control Requirements for Food Manufacturers - Webinar by GlobalCompliancePanel

A Guide for Compliance with Document Control Requirements for Food Manufacturers - Webinar by GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 08-24-2010 Last Day: 08-24-2010 Deadline for abstracts: 08-23-2010
An essential part of the Food and Site Security Plan and the Bioterrorism Act. of 2002 section 306. The control of food safety and quality records as required by customers, regulators and internal audit and legal disciplines. Why you should attend: Document Control indicates to customers that their business is highly valued and that their trade secrets and standards are respected by the supplier or business partner. The document control information is a summary of a larger program and process of demonstrating management commitment, communication and currency. Internally, document control increases product safety and reduces potential liability resulting from inaccurate…
Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements - Webinar by GlobalCompliancePanel

Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements - Webinar by GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 08-24-2010 Last Day: 08-24-2010 Deadline for abstracts: 08-23-2010
Any medical device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices. Devices that have not been approved or cleared in the U.S. must follow the export provisions of the FD&C Act. Foreign firms that manufacture medical devices and/or products that emit radiation that are imported into the United States must comply with applicable U.S. regulations before, during, and after importing into the U.S. or its territories. All medical devices that are imported into the…
Regulatory Requirements for Medical Device Calibration Programs - Webinar by GlobalCompliancePanel

Regulatory Requirements for Medical Device Calibration Programs - Webinar by GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 08-24-2010 Last Day: 08-24-2010 Deadline for abstracts: 08-23-2010
Calibration is an essential component of every Quality Management System (QMS). An effective system includes more than just management of stickers on equipment. This presentation will give you the background need to understand the requirements and effectively implement. The presentation states with the regulatory requirements in the FDAs QSR, ISO 13485, and ISO 9001. After analysis of these requirements, the presentation examines available guidance documents. The FDA issued the Medical Device Quality Systems Manual to help companies implement the Quality system Regulation. Chapter 7 discusses the role of calibration systems in the QMS and helps define the regulatory expectations. ISO…
Software Verification and Validation Planning

Software Verification and Validation Planning

Location: , United States
Category: Health and Medicine
Start Date: 08-24-2010 Last Day: 08-24-2010
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. Areas Covered in the Seminar: - Tougher FDA Expectations / Requirements. - Roles of Verification and Validation. - An FDA "Model". - A Typical Software V&V Protocol / Test Report. - A Brief Overview of 21 CFR Part 11. - Legacy, Hybrid, New and ER / ES Systems. - Expected Regulatory Deliverables. - Complementary Guidelines, e.g., GAMP. For More Details: http://bit.ly/ardQsg
Process Validation for Drugs and Biologics

Process Validation for Drugs and Biologics

Location: , United States
Category: Health and Medicine
Start Date: 08-25-2010 Last Day: 08-25-2010
In this Process Validation training learn how to validate a manufacturing process and do it in a reasonable time. Areas Covered in the Seminar: Validation overview. Retrospective Validation. Installation Qualification. Operational Qualification. Process Qualification (also known as Process Validation). Cleaning Validation. Specific PV applications for Drugs. Specific PV applications for Biologics. For More Details: http://bit.ly/cMr9d9
The DHF, Technical File and Design Dossier - Similarities, Differences and The Future - Webinar by GlobalCompliancePanel

The DHF, Technical File and Design Dossier - Similarities, Differences and The Future - Webinar by GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 08-25-2010 Last Day: 08-25-2010 Deadline for abstracts: 08-24-2010
This webinar will examine the existing and proposed requiements for the FDA's DHF and the MDD's TF/DD. Differing purposes / goals. Differing purposes / goals. Required and desirable contents. Areas requiring frequent re-evaluation / update. Similiarities and differences, and future trends. Typical DHF Table of Contents. Technical File or Design Dossier Table of Contents. The importance and usefulness of the "Essential Requirements". Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed. Parallel approaches to development. Differing approaches to file audits by the FDA and the Notified Body. Areas Covered in the Session: * The EU's MDD and the Technical…
How to prepare for and survive a CLIA inspection - Clinical Laboratories Improvement Act

How to prepare for and survive a CLIA inspection - Clinical Laboratories Improvement Act

Location: , United States
Category: Health and Medicine
Start Date: 08-26-2010 Last Day: 08-26-2010
In this CLIA inspection webinar understand how to get your lab ready for inspection, what the inspectors will look for and how to do inspection follow up and response. Areas Covered in the seminar : - Preparation is the Key. - The Laboratory Walk-Thru. - Personnel Training/Competency Documentation. - Quality Control: The Core of the Inspection Process. - Quality Assessment Plan: What Do You Measure? - Patient Chart/EMR Review. - Inspection Follow-up and Response. - General Guidelines for a Successful Inspection. For More Details: http://bit.ly/cqL8I3
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…
2010 Changes to the EU Variation Rules, Classifications and Submittal Requirements

2010 Changes to the EU Variation Rules, Classifications and Submittal Requirements

Location: , United States
Category: Health and Medicine
Start Date: 08-30-2010 Last Day: 08-30-2010
This European Regulatory webinar is designed to provide an overview on the changes to the variation rules, classifications and filing requirements for all active pharmaceutical, biologics and orphan drug licenses in the EU. Areas Covered in the Seminar: The European Regulatory Structure. How the Commission and Individual Member States within Europe interact. New Rule Changes for Type IA, IB and Type II Variations. New Variation Application Submittal Form. New Variation Guidance Document, including conditions to be met and necessary appended documents per the rule. New Processing Times for EU variations. New Bundling Rules & Fee Payments for EU Variation Submittals.…
Understanding International Standards for Medical Devices

Understanding International Standards for Medical Devices

Location: , United States
Category: Health and Medicine
Start Date: 08-30-2010 Last Day: 08-30-2010
This medical device training on International Standards will address various sources of external standards, how they are developed and the differences from region to region. Areas Covered in the Seminar: - Sources of external standards / documents. . Standards Bodies ISO, CEN, AAMI, etc . Regulations FDA, MDD, CMDR - ISO, EN, BS EN, AAMI/ANSI making sense of the standards alphabet soup. - Harmonized Standards Source, meaning, updates. - Third Party sources of standards, ILI, BSI, etc. - Keeping up to date. . Requirements, resources, transition periods - Copyrights, filing, what standards do you need to…
Auditing vs. monitoring, defining the purpose, application and process

Auditing vs. monitoring, defining the purpose, application and process

Location: , United States
Category: Health and Medicine
Start Date: 08-31-2010 Last Day: 08-31-2010
In this Clinical Trial audit training learn risk-based approach to the process of monitoring and auditing clinical trial Areas Covered in the Seminar: - Background and Definitions. - Roles and Responsibilities. - Symbiosis of Monitoring & Auditing. - Planning & Conduct of Monitoring & Auditing. - Identifying & Handling Possible Fraud And Misconduct. - Ensuring A successful Trial Conduct. - Continuous Improvement. - Past Lessons vs. Future Trials. For More Details: http://bit.ly/9STQWR
Product Risk Management - ISO 14971 and ICH Q9

Product Risk Management - ISO 14971 and ICH Q9

Location: , United States
Category: Health and Medicine
Start Date: 08-31-2010 Last Day: 08-31-2010
In this Product Risk Management webinar learn how to develop and implement product risk management planning. Understand the Key requirements of ISO 14971 and ICH Q9. Areas Covered in the Seminar: - Key requirements of ISO 14971 and ICH Q9. - Suggested formats to meet both FDA and MDD requirements. - Expected sources of information for evaluation and inclusion. - How to compile. - When to involve the team. - How to complete, document and control as a 'living' document. - An often neglected safety feature. - Effectiveness -- Determining and Monitoring. - Realizing real cost savings. Who Will Benefit:…
Clinical Trials International Summit 2010

Clinical Trials International Summit 2010

Location: , China
Category: Health and Medicine
Start Date: 09-01-2010 Last Day: 09-02-2010
Sep.1-2,2010,Shanghai,Clinical Trials International Summit 2010 will be held by JFPS China, supported by Contract Research Organization Union (CROU) and Chinese Pharmacological Society. The event will attract senior clinical trial practitioners from world famous pharmaceutical companies, biotechnology companies, medical device companies,contract research organizations (CRO), laboratories and clinical research centers. Clinical Trial is always regarded as the most time consuming phase in new drugs R&D. In order to shorten the R&D cycle and accelerate the launch of new products, more and more pharmaceutical companies choose to outsource their clinical trials to more professional clinical research organizations. Drug development outsourcing encouraged the booming…
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

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