Investigations and CAPA Training For GCP
INVESTIGATIONS AND CAPA FOR GCP COURSE OVERVIEW:
The PathWise Investigations and CAPA Training Course for GCP Clinical Environments is designed to meet the requirements mandated by world regulatory bodies. The training supports requirements under:
- ICH GCP E6 5.20.1
- ICH GCP E6 5.18.4 Q
- ICH Q10
- International Medical Device Regulations Forum –GHTF/SG5/N3: 2010
and other recognized global regulations. The GCP CAPA training course uses an interactive approach to show how to effectively apply risk-based methodology throughout the investigation process and instructs how to assess and prioritize non-compliances.
The PathWise Investigations and CAPA Training Course for GCP Clinical Environments training course covers four modules. These modules explore the following learning objectives:
- Identify and distinguish between a correction, corrective action and preventive action.
- Assess concerns and evaluate risk.
- Investigate events.
- Gather specifics
- Assess impact
- Make a risk-based decision
- Conduct root cause analysis.
- Systematically find cause(s)
- Establish causal relationships
- Use quality tools: 5 Whys, Fishbone, IS/IS NOT
- Identify a process to verify root cause
- Identify a process to implement corrective/preventive actions.
- Develop an implementation plan
- Deliver results according to the plan
- Check output effectiveness
- Perform closure activities
HIGH IMPACT TOPICS
- Gather specifics to support an investigation.
- Assess impact to process and product through Risk Based Methodology.
- Check effectiveness of solutions implemented.
- Reduce repeat investigations, and eliminate recurring noncompliances.
- Improve root cause identification.
- Improve systems and process, and shorten investigation cycle time.
- Identify most effective actions.
INVESTIGATIONS/CAPA TRAINING ATTENDEES
Investigations and CAPA is appropriate for those who are regularly called upon to resolve problems. Additionally, those whose input would aid in preventing problems. Examples include investigators, laboratory functions, QA/RA functions, managers, and supervisors.
Instructor Led training- Two Days interactive instruction.
Investigations and CAPA 2 day training is worth 1.5 credits.
PathWise is accredited by the International Association for Continuing Education and Training (IACET). PathWise complies with the ANSI/IACET Standard, which is recognized internationally as a standard of excellence in instructional practices. As a result of this accreditation, PathWise is accredited to issue the IACET CEU.
The most cost effective training option is to have PathWise come to your location. We have trainers across the globe, covering almost every continent!
To schedule a course at your site fill out the form below and a PathWise representative will get back with you shortly!
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Chose from these options:
COMPUTER BASED TRAINING
- How to Qualify Lead Investigators for CAPA
- Using the Fishbone Diagram to Identify Root Cause
- How to Document Quality Investigations
- Quality Event Review
ADDITIONAL INSTRUCTOR LED TRAINING COURSES
We understand that training is essential to achieve and maintain a compliant, effective and efficient quality system. As a result, 90% of our courses are taught on-site at our client’s locations. For individuals and organizations in need of training but unable to make an on-site training commitment, we offer many of our courses as events at a variety of locations across the globe.
View the PathWise Events page to find out about our options for a public workshop.