Clinical Trials, Root Cause Analysis (RCA) in Pharmaceutical Industry [Tonex Training]

One of the most crucial factors, challenges for pharmaceutical companies is to complete investigations and actions in a timely manner as instructed by the Food and Drug Administration (FDA).

Clinical Trials, Pharmaceutical Root Cause Analysis

Very often, incorrect assumptions are made that everything is an isolated incident. In other instances, problems are not corrected and everything is blamed on a single employee or a simple laboratory error, or the system fails to ensure that a problem does not extend to other lots and the incident recurs.

Why Root Cause Analysis (RCA) Is Important For Pharmaceuticals Industry ?

Root cause analysis (RCA) is now frequently applied in almost all industries as an effective and reliable ways to find out the original cause of a problem.

It is a significant methodology because it can improve a product or service by providing the way to implement corrective and preventive actions.

The pharmaceutical industry has been particularly active in using RCA in recent years. For the pharmaceutical industry, corrective and preventative actions have become more important than ever.

Clinical Trials And Pharmaceutical Root Cause Analysis Training Courses By Tonex

Clinical Trials and Pharmaceutical Root Cause Analysis Training by Tonex is a 2-day workshop style, hands-on training course, specially designed for professionals in clinical trials, biotech and pharmaceutical industries.

Course Designed For :

• Specialists and professionals in Biotech, pharmaceutical, biologists and medical device
• Pharmacological & Drug Safety Specialist
• Quality assurance and control, safety, risk,
• R&D team

Learning Opportunities :

• Learn the essential theory of root cause analysis and how it is applied to clinical trials and pharmaceutical industry
• Define problem statement
• Use appropriate methods
• Apply brainstorming, process mapping and regulatory resources, tools and techniques
• Learn all the benefits and drawbacks of each solution to figure out the best and the most efficient one
• Watch the implemented solution(s) to assess its effectiveness
• Identify high-risk situations and perform possible preventive actions
• Recognize, Solve common limitations of root cause analysis

Course Outlines :

• Clinical trials introduction
• Pharmaceutical regulatory introduction
• Familiarizing to root cause analysis (RCA)?
• Common root cause analysis tools
• Root cause analysis framework
• Pharmaceuticals case studies
• Workshops on working with root cause analysis frameworks

Want To Learn More ?

Request more information. Call Tonex Training today at +1-972-665-9786 or visit tonex.com for course and workshop detail.

Clinical Trials Pharmaceutical RCA Training