CGMP: Pharmaceutical CAPAs (GMP10)
Duration : 90 Minutes
Kelly Thomas,
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, 21 CFR Part 1 Read more
This online training program describes corrective and preventive actions (CAPAs), and how good manufacturing practices can be applied to eliminate causes of non-conformities or other undesirable situations. The training program enables the students to interpret and identify the requirements of a pharmaceutical CAPA system.
As a fundamental management tool, CAPA is integral to the effectiveness of a quality management system. The objectives of this course are to teach the requirements of ICH Q10- PQS (Pharmaceutical Quality System), describe escalation and tracking processes in a CAPA system, explain the importance of investigation and risk assessment, list a CAPA system's critical elements, explore the different processes and phases of a good CAPA system, and identify a CAPA system's regulatory requirements.
Course Objectives:
• Identify the regulatory requirements for a CAPA system.
• List the various phases and the processes of a successful CAPA system.
• Explain the critical elements of a CAPA system.
• Explain the importance of risk assessment and investigation.
• Describe tracking and escalation processes in a CAPA system.
• Recognize the requirements of ICH Q10 - Pharmaceutical Quality System (PQS).
Course Outline:
INTRODUCTION
• Introduction
• Overview
• Pharmaceutical Quality System (PQS) Model
• Key areas of the QMS
• Reviews and assessments
REGULATIONS
• Overview
• Compliant CAPA systems
• Activity: Looking for CAPA requirements within GMPs
• FDA QSIT inspections of CAPA systems
• Important definitions
• Examples of different CAPAs
• Topic review
THE CAPA SYSTEM
• Overview
• Features of a CAPA system
• CAPA flowchart
• Phases of a CAPA system
• Topic review
ELEMENTS OF CAPA SYSTEMS
• Overview
• CAPA system inputs
• Risk assessment and CAPA
• Risk assessment process
• CAPA documentation
• The CAPA procedure
• CAPA request/record
• Correction/containment
• Corrective action
• Preventive action
• Verification and closeout
• Completed CAPA report
• Topic review
ROOT CAUSE ANALYSIS
• Symptom or Root Cause?
• When to conduct RCA/CAPA
• Root Cause Analysis (RCA)
• Investigation & Analysis
TRACKING AND ESCALATION
• Overview
• Progress tracking and escalation
• CAPA trending
• Topic review
• Summary
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Production personnel
• QA/QC personnel
• R&D managers
• Compliance officers
• Executive managers
• Risk management specialists
• Manufacturing Personnel & Management
• Senior Management
• Regulatory Affairs Personnel & Management
• Quality Assurance Personnel & Management
• Drug development companies
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
Refund / Cancellation policyGet In Touch
Similar Trainings
Training for New Technical Writers
LIVE : Scheduled on
13-January-2025 :01:00 PM EST
|
