Risk Based Monitoring for GCP Compliance

By attending this online training course you will learn how to use risk based assessment for investigational sites and the protocol to implement risk based monitoring. Risk based monitoring roles and responsibilities, Also 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.

Laura Brown
Instructor:
Laura Brown
Date:
Wednesday, March 27, 2019
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
90 Minutes

More Trainings by this Expert   Product Id : 502471

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
Combo Offers
Live + Recorded
$289 $340 Live + Recorded
Corporate (Live + Recorded)
$599 $680 Corporate
(Live + Recorded)
Price Detail Options
Overview:

The rationale for risk based monitoring. The requirements for risk-based monitoring and targeted source data verification (SDV) risks identification.

Critical data and risk indicators analysis. The monitoring plan including risk monitoring and centralized monitoring.

How to use risk based assessment for investigational sites and the protocol to implement risk based monitoring. Risk based monitoring roles and responsibilities.

Why should you Attend: It is essential to comply with the latest GCP requirements to have a risk based monitoring methodology for your clinical trials.

It is also essential to have a quality risk management system in place to allow for risk based monitoring. The FDA and EU regulatory authorities supports clinical trial sponsors to use risk-based site monitoring. For example, the revised ICH GCP guideline R2 Addendum, the EU Clinical Trial Regulation and FDA monitoring guideline all cover risk based monitoring.

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.

Areas Covered in the Session:

  • Understand the new requirements for risk based monitoring in clinical trials
  • Define the regulations and guidelines which cover risk based monitoring
  • Review of risk based monitoring approaches and methodology for clinical trial projects
  • Learn how to identify and evaluate risks for the investigator site and protocol for implementing risk based monitoring
  • Learn how to identify critical data
  • Evaluate the risk indicator and set thresholds
  • Consider how to implement this new concept within your organization
  • Hear best practice of these new risk requirements

Who Will Benefit:
  • Clinical Development Managers And Personnel
  • Clinical Operations Personnel
  • Clinical Research Associates
  • Clinical Research Archiving and Document Management Personnel
  • Quality Assurance Managers and Auditors
  • CROs using Laboratories to Analyze Clinical Trial Samples
  • Project Management
  • Sponsors and Non-Commercial Sponsors
  • Consultants
  • Laboratories Analyzing Samples from Clinical Trials
  • Regulatory Affairs Personnel
  • Legal and Regulatory Authorities


Speaker Profile
Dr. Laura Brown , PhD, MBA, Diploma Clinical Sciences, is an independent QA and training consultant in the pharmaceutical industry. She is a managing director with LB Training and Development Ltd., course director for the M.Sc. in Clinical Research, School of Pharmacy at the University of Cardiff, and course director for M.Sc. Regulatory Affairs, TOPRA. Dr. Brown has 20 years experience running clinical trials and clinical quality assurance in the pharmaceutical industry, and auditing clinical trials internationally. She has held a number of international and senior management QA positions in the pharmaceutical industry including her role as an associate director with a leading GCP audit consultancy.

She has worked for several international companies like GlaxoWellcome, Hoechst Marion Roussel and Phoenix International. Dr. Brown has published material on the new EU Clinical Trial Regulation and also a practical guide to the current regulatory requirements for carrying out clinical trials in the EU. She has penned a chapter on training QA staff in the leading GXP book “Good Clinical, Laboratory and Manufacturing Practices” (2007). She has authored SCRIP’s latest GCP guide and one entitled “Practical Guide to the Clinical Trial Directive”. She is also co-author of several books including “Developing the Individual” and “Project Management for the Pharmaceutical Industry”. She has regularly lectured at conferences and in training courses on QA and GXP issues.

Dr. Brown developed an e-learning module: “How to Prepare for Audit and Inspection” for Zenosis (a regulatory commercial e-learning training organization) in 2008 and is editor of an e-learning SOP series for Henry Stuart Conferences (2013). She runs many training courses on topics such as: pharmaceutical project management, understanding the pharmaceutical industry/drug development, writing and managing SOPs, GCP, regulatory requirements for clinical trials, the clinical trial directive, managing clinical trials, QA management and business skills, how to prepare for audit and inspection, how to audit, etc.




Your Recently Viewed Webinars

Payment Methods

Contact Us

NetZealous LLC,
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.

Information

  Refund Policy
  +1-800-447-9407
  Fax: 302 288 6884
  support@compliance4All.com