ComplianceOnline

Clinical Research Risk Management Regulatory Compliance Training - Live Webinars, Recordings & CDs

Recorded/CD
Trial Master File and Clinical Data Management Regulated by FDA

Trial Master File and Clinical Data Management Regulated by FDA

  • Speaker: Carolyn Troiano
  • Product ID: 705360
  • Duration: 60 Min
This FDA compliance training will cover in detail the new requirements for trial master files including documents related to clinical trials that are required to be prepared, collected and maintained as part of the TMF.
CD/Recorded
$249
Recorded/CD
Risk Based Monitoring for GCP Compliance

Risk Based Monitoring for GCP Compliance

  • Speaker: Laura Brown
  • Product ID: 705052
  • Duration: 60 Min
This Webinar will help you how to ensure that your data and supporting documentation are in the appropriate format to comply with regulatory authority inspection. Risk based monitoring can contribute to better oversight and more efficient use of resources of clinical studies.
CD/Recorded
$249
Recorded/CD
How to prepare a winning Standard Operating Procedure (SOP)

How to prepare a winning Standard Operating Procedure (SOP)

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705131
  • Duration: 60 Min
This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.
Recorded/CD
Prospects for Change at FDA Under the Trump Administration: Early View of What 2017 Will Bring

Prospects for Change at FDA Under the Trump Administration: Early View of What 2017 Will Bring

  • Speaker: Steven Grossman
  • Product ID: 705023
  • Duration: 90 Min
This webinar will discuss FDA's current priorities and the agency's likely priorities and the future of regulations and policies in 2017 under the new Trump administration.
CD/Recorded
$199
Recorded/CD
Project Risk Management

Project Risk Management

  • Speaker: Mario Mosse
  • Product ID: 705015
  • Duration: 90 Min
Project risk management includes the processes of conducting risk management planning, identification, analysis, action planning, and controlling risk on a project. This training program will analyze the objectives of project risk management - to increase the likelihood and impact of positive outcomes while decreasing the likelihood and impact of negative events affecting the success of the project.
CD/Recorded
$229
Recorded/CD
Selection and Management of Contract Vendors

Selection and Management of Contract Vendors

  • Speaker: Peggy Berry
  • Product ID: 704884
  • Duration: 90 Min
This webinar will discuss approaches to selecting vendors to perform manufacturing and testing activities as well as clinical study activities. The information obtained will enable implementation of an effective vendor selection program and a comprehensive vendor management and oversight program. The webinar will address aspects of requesting bids, performing audits, evaluating risks, and preparing plans and agreements for effective oversight and management.
Recorded/CD
Defining and Managing Protocol Deviation/Violation/Exception

Defining and Managing Protocol Deviation/Violation/Exception

  • Speaker: Calin Popa
  • Product ID: 704953
  • Duration: 90 Min
This webinar will teach you how to downsize the risk of noncompliance during the development of a clinical trial by helping you to understand, correct and prevent potential protocol deviations/violations.
Recorded/CD
The New EU Clinical Trial Regulation

The New EU Clinical Trial Regulation

  • Speaker: Robert J Russell
  • Product ID: 703758
  • Duration: 90 Min
This course will present attendees with a clear understanding of the new processes and requirements for EU sponsors of clinical trials as the new regulation is published, rolled-out and implemented by the Member States, the European Medicines Agency and the European Commission.
CD/Recorded
$279
Recorded/CD
Risk-Based Monitoring Beyond the RACT

Risk-Based Monitoring Beyond the RACT

  • Speaker: Beat Widler
  • Product ID: 704721
  • Duration: 60 Min
This training program will explain what the strengths and weaknesses of the RACT are and where it should be used with caution. It will also elaborate on what needs to be done to establish a comprehensive risk management approach to support risk-based quality management in clinical trials.
Recorded/CD
Achieving Research Compliance Through Risk Assessment

Achieving Research Compliance Through Risk Assessment

  • Speaker: Sarah Fowler Dixon
  • Product ID: 704689
  • Duration: 60 Min
This training program will analyze the importance of research risks defined in 21 CFR 50 and 45 CFR 46. It will delve into how research risks affect IRB approval and review based on allowable actions in 21 CFR 50. The program will also discuss the need for indemnification language in consent forms based on risk levels.
Recorded/CD
ICH Addendum and its Implication on Clinical Development

ICH Addendum and its Implication on Clinical Development

  • Speaker: Beat Widler
  • Product ID: 704636
  • Duration: 60 Min
This training program will discuss investigator oversight and responsibilities, records management including source data, trial data handling and procedures, quality and risk management, vendor oversight and subcontracting, risk-based monitoring and last but not least root cause analyses in case of non-compliances.
Recorded/CD
FDA Guidance on RUO (Research Use Only)/IUO (Investigational Use Only) Products

FDA Guidance on RUO (Research Use Only)/IUO (Investigational Use Only) Products

  • Speaker: Dev Raheja
  • Product ID: 703898
  • Duration: 60 Min
This FDA guidance training on RUO (Research Use Only) and IUO (Investigational Use Only) products will enumerate FDA requirements for research use only and investigational use only IVD products. The webinar instructor, an industry expert, will highlight appropriate labeling and distribution practices for RUO and IUO products and detail instructions for use of an IVD product labeled RUO or IUO.
CD/Recorded
$25
Recorded/CD
Blinding of Investigational Materials

Blinding of Investigational Materials

  • Speaker: Donald Levine
  • Product ID: 703674
  • Duration: 90 Min
This webinar will introduce attendees to the basics concepts and techniques of blinding of investigational drug products. It will also provide an understanding of the complexities of the work required to prepare blinded products for clinical trials.
CD/Recorded
$25
Recorded/CD
Major Changes to Clinical Trials in Europe - The New EU Clinical Trials Regulation - What Can We Expect for Compliance?

Major Changes to Clinical Trials in Europe - The New EU Clinical Trials Regulation - What Can We Expect for Compliance?

  • Speaker: Laura Brown
  • Product ID: 703695
  • Duration: 60 Min
This webinar will help ensure attendees are familiar with new regulations for running clinical trials in Europe. It will help them prepare to implement the new requirements efficiently while elaborating how clinical trials will be authorized in the future. The instructor will also detail the authority proffered to EU regulators to perform inspections of all clinical trials registered in the EU, whether they are conducted within the EU or internationally in other emerging markets.
CD/Recorded
$229
Recorded/CD
How to respond to GXP (GCP, GLP, GMP, GPV) Inspection and Audit Findings using Correction and Preventative Action (CAPA)

How to respond to GXP (GCP, GLP, GMP, GPV) Inspection and Audit Findings using Correction and Preventative Action (CAPA)

  • Speaker: Laura Brown
  • Product ID: 703160
  • Duration: 60 Min
This webinar will help attendees understand how to respond to inspection and audit findings using CAPA (Correction and Preventative Action) for all types of GXP inspections and audit (eg GCP, GLP, GMP, GPV).
CD/Recorded
$229
Recorded/CD
Optimal Clinical Supply Planning for Global Drug Development

Optimal Clinical Supply Planning for Global Drug Development

  • Speaker: Vladimir Shnaydman
  • Product ID: 702552
  • Duration: 60 Min
This webinar will discuss how to manage supply chain risk to optimize clinical trial supply and also manage demand side requirements, risk of stock out, cost management etc using novel tools and technologies.
CD/Recorded
$229
Recorded/CD
When does GCP Non-compliance at an investigator site compromise a regulatory submission? To File Or Not To File - that is the question!

When does GCP Non-compliance at an investigator site compromise a regulatory submission? To File Or Not To File - that is the question!

  • Speaker: Stephen Schwartz
  • Product ID: 702519
  • Duration: 75 Min
This webinar will help you manage the risks associated with GCP non-compliance at a pivotal investigator site. The training will follow a case-study approach to help you learn how to determine investigator non-compliance and guide you in deciding whether or not to file the efficacy study data in a regulatory application.
CD/Recorded
$229
Recorded/CD
Interpreting FDA's New Guidance Document on Risk-based Monitoring

Interpreting FDA's New Guidance Document on Risk-based Monitoring

  • Speaker: Moe Alsumidaie
  • Product ID: 702485
  • Duration: 60 Min
This webinar will train you on interpreting FDA's new guidance document on risk-based monitoring. It will include a case study demonstration on how any biopharmaceutical, medical device, and CRO could leverage the applications of breakthrough techniques to implement risk-based monitoring.
CD/Recorded
$229
Recorded/CD
An Overview of Risk Management and Risk Analysis Techniques in Clinical Trials

An Overview of Risk Management and Risk Analysis Techniques in Clinical Trials

  • Speaker: Mukesh Kumar
  • Product ID: 702308
  • Duration: 90 Min
This webinar will provide you with an overview of risk factors in clinical trials and discuss possible ways to mitigate, control, assess impact, and prevent them in your trial.
CD/Recorded
$229
Recorded/CD
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

  • Speaker: Madhavi Diwanji
  • Product ID: 701980
  • Duration: 90 Min
This Clinical trial auditing training will provide an understanding of how to conduct compliant and successful clinical trials by defining FDA clinical trial audit procedures, audit program, audit planning and audit preparation.
CD/Recorded
$229
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