World Conference Calendar

32801 Conferences

Conferences of globalcompliancepanelrss


Drug dissolution testing and establishing plasma drug levels in humans 2017

Drug dissolution testing and establishing plasma drug levels in humans 2017

Location: , United States
Category: Health and Medicine
Start Date: 10-26-2017 Last Day: 10-27-2017 Deadline for abstracts: 10-24-2017
Course "Drug dissolution testing and establishing plasma drug levels in humans" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Drug dissolution testing is an essential and critical step for appropriate and efficient product development such as tablet and capsule. A number of approaches are used to conduct dissolution testing using different apparatuses and methods. Making a choice for an appropriate apparatus and method has always been confusing and challenging. This seminar will provide relevant pharmacokinetics and physiological background so that making this choice becomes easier and instinctive.…
Complaints, Adverse Event Reporting, and Recalls - An Integrated Approach 2017

Complaints, Adverse Event Reporting, and Recalls - An Integrated Approach 2017

Location: , United States
Category: Health and Medicine
Start Date: 10-26-2017 Last Day: 10-27-2017 Deadline for abstracts: 10-24-2017
Course "Complaints, Adverse Event Reporting, and Recalls - An Integrated Approach" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Medical Device manufacturers operate in numerous regulatory systems that often have different requirements and are not always consistent. The new ISO 13485:2016 emphasizes this problem. Manufacturers must identify their roles, identify the regulatory requirements for that role, and incorporate them into the quality management system. The various jurisdictions, however, deal with post-market device issues in many different ways. The quality management system, QMS, needs three interlocking process: complaint…
Tougher Import Rules for FDA Imports in 2017

Tougher Import Rules for FDA Imports in 2017

Location: , United States
Category: Health and Medicine
Start Date: 10-26-2017 Last Day: 10-27-2017 Deadline for abstracts: 10-24-2017
Course "Tougher Import Rules for FDA Imports in 2017" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion Overview: Background: FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures. Firms that fail to understand and properly execute an import and export program find their shipments delayed, detained or refused. As of December 2016, FDA and CBP officially implemented the Automated Commercial Environment (ACE) entry filing system. You either meet ACE requirements…
The EU Clinical Trial Regulation + EU Filings & Registrations 2017

The EU Clinical Trial Regulation + EU Filings & Registrations 2017

Location: , Switzerland
Category: Health and Medicine
Start Date: 11-02-2017 Last Day: 11-03-2017 Deadline for abstracts: 11-01-2017
Course "The EU Clinical Trial Regulation + EU Filings & Registrations" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Directive and the impending changes coming to the EU through the EU Clinical Trial Regulation (for Drugs, Biologics & Combination Products). The course also covers recent updates on EU-GCP associated with the new regulatory framework, the highlights of the new EU Pharmacovigilance Directive, as it relates to studies…
HIPAA Privacy and Security - Time to get Serious 2017

HIPAA Privacy and Security - Time to get Serious 2017

Location: , United States
Category: Health and Medicine
Start Date: 11-02-2017 Last Day: 11-03-2017 Deadline for abstracts: 11-01-2017
Overview: This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule and any other applicable updates for 2017 and beyond. There are an enormous amount of issues and risks for covered entities and business associates these days. I will speak on specific experiences from over 17 years of experience in working as an outsourced compliance auditor, expert witness on multiple HIPAA cases, and thoroughly explain…
Onsite GCP Review and Update including the all-important 'Investigators Responsibility' 2017

Onsite GCP Review and Update including the all-important 'Investigators Responsibility' 2017

Location: , United States
Category: Health and Medicine
Start Date: 11-02-2017 Last Day: 11-03-2017 Deadline for abstracts: 11-01-2017
Course "Onsite GCP Review and Update including the all-important 'Investigators Responsibility'" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This seminar is designed to acquaint all Participants with the Rules and Regulations that form the background of what is know as the GCP of Clinical Research. To follow "The Good Clinical Practices" (GCP) is to follow the standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trails that provides assurance that the data and reported results are credible and accurate and, most…
Medical Device Software: An Incremental Approach to Risk and Quality Management 2017

Medical Device Software: An Incremental Approach to Risk and Quality Management 2017

Location: , United States
Category: Health and Medicine
Start Date: 11-02-2017 Last Day: 11-03-2017 Deadline for abstracts: 11-01-2017
Course "Medical Device Software: An Incremental Approach to Risk and Quality Management" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Engineers are dedicated to making things work, so a focus on how they might fail and harm someone can seem alien. Managing risk, however, is essential for all medical products- medical devices, including those involving software, have produced some painful examples of poor risk management with serious consequences. Experience has shown that there is a better way, that it is possible to manage risk in a changing…
Medical Device Registration and Approval Process for the Pacific Rim  2017

Medical Device Registration and Approval Process for the Pacific Rim 2017

Location: , Singapore
Category: Health and Medicine
Start Date: 11-06-2017 Last Day: 11-07-2017 Deadline for abstracts: 11-05-2017
Course "Medical Device Registration and Approval Process for the Pacific Rim (including India, Japan, China, Singapore, Australia, Taiwan, Hong Kong, and other locations)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Classification systems differ from that of the United States or European Union in select countries Medical devices are classified depending on their risk level Medical devices must also comply with additional country standards and these standards define industry-wide safety and performance requirements Regulatory registration process is defined for China, Hong Kong, India,…
Statistics for the Non-Statistician 2017

Statistics for the Non-Statistician 2017

Location: , United States
Category: Health and Medicine
Start Date: 11-09-2017 Last Day: 11-10-2017 Deadline for abstracts: 11-08-2017
Course "Statistics for the Non-Statistician" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: If statistical analysis is not properly performed and/or understood, a firm can run the risk of distributing the kind of product to the market that ultimately fails, resulting in lost time and money. Statistics of course, requires constant practice. This seminar will be highly interactive and participative. Participants apply their learning of statistics to real-world example data sets. The program begins by providing a basic overview of the most common statistical tools and terms.…
GMP and Regulatory Expectations for Early IND Products 2017

GMP and Regulatory Expectations for Early IND Products 2017

Location: , South Korea
Category: Health and Medicine
Start Date: 11-09-2017 Last Day: 11-10-2017 Deadline for abstracts: 11-07-2017
Course "GMP and Regulatory Expectations for Early IND Products" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course will present, in one place, the regulations and guidelines that apply to early phase products. In some cases these will not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process. The course will present these items in the order of product development from the point of R & D activities to the completion of Phase 2…
Project Management for Non-Project Managers 2017

Project Management for Non-Project Managers 2017

Location: , United States
Category: Health and Medicine
Start Date: 11-09-2017 Last Day: 11-10-2017 Deadline for abstracts: 11-07-2017
Course "Project Management for Non-Project Managers" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This two-day seminar will begin by laying the foundation for the subject by first defining what a project is and then discussing the unique roles that the project manager must assume along the length of any project. The Triple Constraint, the most fundamental of project management principles, will be explained in detail with examples and tools provided that can be used to integrate the principle into any project management process. Each stage of…
Statistical Methods: A Visual Approach 2017

Statistical Methods: A Visual Approach 2017

Location: , United States
Category: Health and Medicine
Start Date: 11-09-2017 Last Day: 11-10-2017 Deadline for abstracts: 11-07-2017
Course "Statistical Methods: A Visual Approach" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: An essential task in any compliance analytics workflow is to not only explore your data visually, but also to communicate your results professionally with graphic displays. Do you have the tools and skills to quickly and thoroughly perform these tasks? This course in data visualization will present methods to allow you to interactively discover relationships graphically. We will provide the foundations for creating better graphical information to accelerate the insight discovery process and…
21 CFR Part 11 Compliance for Computer Systems Regulated by FDA 2017

21 CFR Part 11 Compliance for Computer Systems Regulated by FDA 2017

Location: , United States
Category: Health and Medicine
Start Date: 11-09-2017 Last Day: 11-10-2017 Deadline for abstracts: 11-07-2017
Course "21 CFR Part 11 Compliance for Computer Systems Regulated by FDA" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability. FDA's 21 CFR Part 11 was enacted in the late 1990s and…
GMP and Regulatory Expectations for Early IND Products

GMP and Regulatory Expectations for Early IND Products

Location: , Taiwan
Category: Health and Medicine
Start Date: 11-13-2017 Last Day: 11-14-2017 Deadline for abstracts: 11-12-2017
Course "GMP and Regulatory Expectations for Early IND Products" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course will present, in one place, the regulations and guidelines that apply to early phase products. In some cases these will not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process. The course will present these items in the order of product development from the point of R & D activities to the completion of Phase 2…
Design of Experiments and Statistical Process Control for Process Development and Validation 2017

Design of Experiments and Statistical Process Control for Process Development and Validation 2017

Location: , Malaysia
Category: Health and Medicine
Start Date: 11-16-2017 Last Day: 11-17-2017 Deadline for abstracts: 11-14-2017
Course "Design of Experiments and Statistical Process Control for Process Development and Validation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course will present the procedures that must be used in the application of DOE and SPC to the development, design and monitoring of manufacturing and testing processes. A practical approach with case studies and examples will be used, with theoretical information introduced only when necessary to understand an experiment. Examples from real processes and testing procedures will be used to present the student with examples…
Implementing ISO 13485:2016

Implementing ISO 13485:2016

Location: , United States
Category: Health and Medicine
Start Date: 11-16-2017 Last Day: 11-17-2017 Deadline for abstracts: 11-14-2017
Course "Implementing ISO 13485:2016" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: The final version of ISO 13485:2016 is now available and companies should be planning their implementation. There are significant changes from the earlier version; they will require major modifications to the Quality Management System (QMS). The new version has better alignment with FDA's QSR, but there are still major differences that create issues for effective QMS implementation. This workshop covers the differences from the 2003 version to the 2016 version and offers practical implementation advice…
Compliance Boot Camp 2017

Compliance Boot Camp 2017

Location: , United States
Category: Health and Medicine
Start Date: 11-16-2017 Last Day: 11-17-2017 Deadline for abstracts: 11-14-2017
Course "Compliance Boot Camp" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This 2-day seminar will cover the essentials of compliance for medical device companies. An efficient and effective quality system can be a competitive advantage for companies by leading to improved quality and compliance as well as optimizing the cost of quality. This "Compliance Boot Camp" will get you started in setting up just such a Quality System. We'll discuss the "case for quality" and how you can use compliance, not as an end itself, but…
HIPAA Compliance for Small Healthcare Providers 2017

HIPAA Compliance for Small Healthcare Providers 2017

Location: , United States
Category: Health and Medicine
Start Date: 11-16-2017 Last Day: 11-17-2017 Deadline for abstracts: 11-14-2017
Overview: Being in compliance with HIPAA involves not only ensuring that you provide the appropriate patient rights and controls on your uses and disclosures of Protected Health Information; but that you also have the proper policies and procedures in place. If audited or the subject of a compliance review, you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the fundamentals of a HIPAA compliance program. If your small healthcare practice needs to understand how to…
A Risk Based Approach to Testing of Computerized GxP Systems 2017

A Risk Based Approach to Testing of Computerized GxP Systems 2017

Location: , United States
Category: Health and Medicine
Start Date: 11-16-2017 Last Day: 11-17-2017 Deadline for abstracts: 11-14-2017
Course "A Risk Based Approach to Testing of Computerized GxP Systems" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Testing is the science of identifying defects, so that they can be corrected, and of demonstrating that a system meets intended requirements. Testing computerized systems is considered a fundamental verification activity and appropriate testing is a regulatory expectation as described in many regulations e.g. EU GMP Annex 11. "Evidence of appropriate testing methods and test scenarios should be demonstrated. Particularly system (process) parameter limits, data limits and error…
Auditing Analytical Laboratories for FDA Compliance 2017

Auditing Analytical Laboratories for FDA Compliance 2017

Location: , Philippines
Category: Health and Medicine
Start Date: 11-20-2017 Last Day: 11-21-2017 Deadline for abstracts: 11-19-2017
Course "Auditing Analytical Laboratories for FDA Compliance" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted. Who will benefit: The following specific types of workers will benefit from…

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