Quality Performance Improvement
Training Synopsis
This training is designed to provide participant an understanding on FDA Inspectors expectation of CAPA and documenting excellent CAPA investigation report and a in order to demonstrate that the company is operating under cGMP.
Introduction
Learning Objective
Duration
Methodology
Target Participants
Course Outline
Training Certificate
Why Us?
Introduction
This training course provides an understanding on FDA Inspectors expectation of CAPA in order to demonstrate that your company is operating under cGMP. Learn how to define problem, perform root cause analysis and implement effective CAPA. This course incorporates the approach of risk assessment into CAPA process. Participants will be given tips on documenting excellent CAPA investigation report and have opportunity to apply the techniques in case studies.
Learning Objective
By the end of the training, participants would be able to:
- Appreciate the principles of CAPA
- Prepare good CAPA investigation report
- Apply risk assessment into CAPA
- Apply CAPA process that is efficient and effective
- Identify regulatory requirements and FDA inspector expectations related to CAPA
Duration
2 days (9.00am to 5.00pm) or duration proposed at quotation.
Methodology
Training session includes classroom lecture, exercises, group work and discussion.
Target Participants
This course is designed for any personnel who are involved or participate as a team member in failure investigations and corrective actions. Personnel responsible for customer complaints, quality issues, compliances and process improvements.
Course Outline
- Introduction – Overview of FDA regulations for CAPA
- Basic Understanding of CAPA – Definitions and its importance
- Effective Investigations
- Problem Description (Identify and writing Problem Description)
- Root Cause Analysis (Use various tools to perform process-based root cause analysis)
- CAPA Plan (Develop, Implement and Verify the Corrective Actions are effective)
- Application of Risk Assessment into CAPA
- Technical writing skills to document excellent investigation and CAPA report
- What the FDA Investigator expect to see during an inspection?
- Case Studies and Discussion
Training Certificate
Certificate of Attendance will be issued to participants who fully participated the training and satisfied the attendance requirements.
Why Engage aNTS / Peplow-Warren?
Peplow-Warren Consultant Team is formed by a group of experienced sector expert, certification auditors, consultants and industry practitioners. They actively involve in international standard and specifications development by acting as active ISO and MOSTI Technical Committee Member. They carry a common mission: they are willing to share their good knowledge with current industry practitioners. Call us today for more detail. We are obliged to work together and grow your business.
Investment
Contact our Customer Care Hotline 012-713 3356 / 011-2128 4750 or email to ntsask@gmail.com / sales@peplow-warren.com for your best solution and offer.