Quality Assurance in Clinical Trials

Event Information
Product Format
Prerecorded Event
Presenter(s)
Length
90 Minutes
Product Description

Manage Quality in Clinical Trials – Learn from the expert!

Quality systems must be in place during the planning stages of clinical trials. It is important for the organizations that conduct clinical trials to monitor processes right from the outset of data collection to result publication. The clinical research results need to be of the highest quality and a robust QA unit will go a long way in ensuring the credibility of the research results.  

Get expert tips and strategies for planning and conducting Quality Assurance during a clinical trial with our presenter Richard Chamberlain. This session is useful to anyone in a hospital, clinic or a CRO who might be involved in conducting a clinical trial. The session will take you through the different types of trials – Phase I through Phase IV and the usual steps done during a trial.


You will get the answer to these questions in this session:

  • What is Quality Management - Quality Manual, Policies & Procedures
  • What part of Quality Assurance you must focus on?
  • How to ensure accurate data source  and data collection?
  • Quality Assurance/Quality Control- What you are supposed to do and How you do it.
  • How to plan and conduct the QA?
  • Quality and the Regulations
  • What needs to be done after the last subject visit
  • What is CAPA?
  • Data collection audit & protocols
  • What is the Source Data – Strong Regulatory Consideration?
  • Source data- ALCOA and ECs
  • QA by the Sponsor- Data Management, Project Management, Clinical Monitoring
  • QA at the Site
  • What & Why to QA?
  • Beyond Clinical Trials – A Prediction
  • Is the Laboratory GLP Compliant?
  • Is Study Medication Proper?
  • Are Diagnostic Equipment/Procedures Proper  - ECGs, X-rays, MRIs, Scans, etc.?
  • Are Paper Records Stored for Accurate Retrieval?
  • And much more…


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About Our Speaker

Dr. Richard Chamberlain - Pharma Compliance Expert

Dr. Richard Chamberlain has provided executive consulting services to numerous Pharmaceutical, Biotechnical, Medical Device companies, and international Contract Research Organizations in the areas of strategic planning project management for the development of computerized project management tools and Computer Systems Validation.

Richard
managed large-scale clinical projects from the project planning phase until project closure. He has taught numerous public and in-house courses on various topics such as: Computer Systems...   More Info
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