WEBINARS

 

Clinical Regulatory Compliance Training - Live Webinars, Recordings & CDs

How to conduct a Clinical Trial in accordance with FDA regulations and how to avoid the common deficiencies observed during FDA clinical audits

webinar-speaker   Elizabeth Bergan

webinar-time   90 Min

Product Id: 701054

This Clinical Trial training will provide a detailed review of the FDA regulations for Clinical Trials Process. This presentation will provide a detailed review of the FDA regulations for Clinical Trials Process. After attending this session, participants will have an understanding of FDA regulations pertaining to the implementation of clinical trials and concepts of Good Clinical Practice (GCP) and Bioethics.

Recording Available

* Per Attendee $199

 

Clinical Trials Process: Study Sponsor's and Investigator's Responsibilities

webinar-speaker   Elizabeth Bergan

webinar-time  

Product Id: 701095

FDA Regulations and Good Clinical Practice Guidelines will be discussed with an emphasis on data integrity and the protection of study subject’s welfare/rights. This course will provide an overview of the Clinical Trial Process. It will discuss in detail the responsibilities of the Sponsor (company or institution managing the trial) and Investigators conducting a clinical trial.

Recording Available

* Per Attendee $299

 

Deploying Regulatory-Compliant Clinical Research Data Management Systems

webinar-speaker   Dale Hunscher

webinar-time   60 Min

Product Id: 701068

This presentation covers the fundamental principles underlying the various compliance regulations and discusses their implications for system designers and integrators. Electronic data capture and management systems for clinical research must support many kinds of research, including clinical trials, prospective observational studies, and retrospective "chart mining". Regulatory requirements for new drug and device trials are the most stringent and complex, but even the smallest investigator-initiated study in an academic health center or community hospital or clinic must comply with human subject protection regulations and professional ethical guidelines, and meet information security requirements such as the HIPAA Privacy and Security Rules. This presentation covers the fundamental principles underlying the various compliance regulations and discusses their implications for system designers and integrators.

Recording Available

* Per Attendee $249

 

Using Electronic Health Records and Claims Databases for Rapid-Response Pharmacovigilance Studies

webinar-speaker   Alan Hochberg

webinar-time   60 Min

Product Id: 700972

This presentation will give an overview of these new tools and techniques for the non-statistician/epidemiologist. It is vital that a pharmaceutical manufacturer be able to quickly assess these issues on a sound statistical basis, in a way that eliminates bias due to confounding factors as much as possible.

Recording Available

* Per Attendee $299

 

Clinical Research Organization Audit for Good Clinical Practice

webinar-speaker   Ronald Schoengold

webinar-time   90 Min

Product Id: 700907

This Webinar defines the role of the CRO to ensure that each party is meeting its responsibilities. CRO audits ensure that the study data and results are credible and accurate, and that the rights and well-being of study subjects have been protected.

Recording Available

 

Organization of Clinical Datasets in eCTD Submissions

webinar-speaker   Antoinette Azevedo

webinar-time   90 Min

Product Id: 700992

This presentation will review the documentation requirements, the electronic navigation aids required for all the components of the electronic datasets package for a clinical study. This webinar will provide valuable assistance to all pharmaceutical and biotechnology that are conducting clinical studies with the intent of filing Investigational New Drug (IND) and New Drug Applications (NDA) or Biological License Applications (BLA) submissions.

Recording Available

* Per Attendee $249

 

Data and Safety Monitoring in Clinical Research Involving Human Subjects - When and How

webinar-speaker   Charles H Pierce

webinar-time   90 Min

Product Id: 700924

This webinar will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. All Clinical Research protocols have a prominent safety monitoring plan as part of the overall research plan / protocol. This "plan" is to ensure the safety of participating subjects and to ensure the validity and integrity of the data.

Recording Available

* Per Attendee $299

 

Utilizing ICH Guidelines for GCP Regulatory Compliance

webinar-speaker   Carl Anderson

webinar-time   60 Min

Product Id: 700855

This presentation reviews key ICH guidelines to directly correlate them with FDA Compliance Program Guidance Manuals that FDA investigators use to conduct GCP inspections. This webinar will provide critical assistance to FDA regulated companies currently conducting or preparing to conduct clinical trials.

Recording Available

* Per Attendee $299

 

Preparing Compliant eCTD Submissions

webinar-speaker   Antoinette Azevedo

webinar-time   60 Min

Product Id: 700719

This webinar will provide valuable assistance to all companies regulated by FDA to understand the current and impending requirements for electronic submissions. The immediate impact is to companies submitting INDs and marketing applications for pharmaceutical and biological products.

Recording Available

* Per Attendee $249

 

Validation of Computerized Analytical Systems

webinar-speaker   Dr. Ludwig Huber

webinar-time   60 Min

Product Id: 700212

This Validation training will give a good understanding on what the requirements are and how to validate laboratory computer systems in the most cost-effective way.

Recording Available

* Per Attendee $249

 

Implementing Clinical Trial Performance Metrics

webinar-speaker   Dr. Carla Hagelberg

webinar-time   60 Min

Product Id: 700182

This Clinical Trial training will helps in implementing Metrics that can be used as clinical trial performance improvement indicators.

Recording Available

* Per Attendee $149

 

How to Buy COTS Software, and Audit and Validate Vendors

webinar-speaker   David Nettleton

webinar-time  

Product Id: 703820

This training program will focus on instructing attendees on best practices for buying COTS (Commercial Off-The-Shelf) software and to evaluate a software vendor. It will also highlight key data and systems subject to Part 11, and list requirements for IT, SaaS, and cloud hosting.

Recording Available

 

Key Factors to Develop an Effective CAPA System

webinar-speaker   Kim Huynh-Ba

webinar-time  

Product Id: 703320

This training will focus on the regulatory requirements for a Corrective and Preventive Actions (CAPA) system. Attendees will learn how to develop an effective CAPA system.

Recording Available

 

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