CAPA and Root Cause Analysis: Essentials Post ICH GCP E6 (R2) Addendum
$279.00 – $2,550.00
Do you have a system in place to prevent noncompliance and to ensure effective action planning with follow-up in the event of a significant deviation? The ICH E6 GCP updates expects that you do!
Attend our webinar training on the essentials of CAPA and Root Cause Analysis to apply to your clinical trials!
Description
COURSE DESCRIPTION
OVERVIEW
ICH E6 GCP update expects that sponsors and contract research organizations (CROs) have systems in place to prevent noncompliance and for significant deviations ensure effective action planning with follow-up. When noncompliance does occur, strong Root Cause Analysis (RCA) investigations should take place that result in effective corrective and preventive measures (CAPA). Inspection findings worldwide reveal that sponsors and investigators fail to have effective CAPA processes. These risky deficiencies comes from 1) gaps in process, and 2) gaps in the skills of those performing RCA and CAPA.
This session will provide you and your colleagues training on the essentials of CAPA and Root Cause Analysis. Neither is an inherent skill, and cannot be completed effectively with only using popular tools, (e.g., Fishbone Diagrams). This interactive session will provide you with an overview of what you need to do to prepare and successfully execute RCA investigations that will lead to appropriate interventions. You will work through specific use cases for clinical trials to support the correct application of RCA for clinical trials. The training also includes suggestions for action planning to support application, and underscores that “practice is essential” for successful RCA and CAPA programs.
LEARNING OBJECTIVES
This 90-minute course will provide you with the essential information you need in regard to understanding CAPA and Root Cause Analysis, and application strategies. Join us and understand what has changed, what hasn’t, and discover what will matter most with these recent changes.
By attending this interactive live session, you will be able to:
- Recognize needed changes to your strategies for trial issues management related as a result of ICH GCP E6 (R2).
- Apply the steps of CAPA and RCA to a clinical trial use case.
- Identify how CAPA and RCA may be applied for your role.
- Discuss challenges and opportunities in implementing CAPA and RCA.
WHO SHOULD ATTEND
This course will be valuable to anyone working in clinical trials. Specifically, this course will be of greatest benefit to those working in clinical operations, clinical quality, and monitoring roles. Additionally, this session will be of value to senior management and those who work in regulatory affairs, plus anyone who is affected by the quality of trial performance.
WHAT TO EXPECT
HOW TO PARTICIPATE
This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.
THE TRAINING PLATFORM
Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.
USER AGREEMENT
Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.
Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 and use Option 3 (9am – 5pm EST, M-F) for assistance.
Additional information
| Format | Recorded Only |
|---|---|
| Participants | Single Participant, 5 Participant Value Package, 10 Participant Value Package |
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