Internal audits are a fundamental part of implementing, maintaining, and improving your quality system which is critical to your business’ success. Whether you work for a pharmaceutical company complying with “selfinspection” requirements of the PIC/S Guide to GMP or a medical device company complying with “internal audit” requirements of ISO 13485, deploying an internal audit program throughout your organisation will help educate personnel, confirm ownership of various quality system elements, and ultimately drive continuous improvement and cost reductions.
Internal audits deliver value irrespective of how mature your organisation’s quality system is. Do you need help optimizing and delivering more value from your self-inspection/internal audit program? This course can help you achieve your KPIs.
Content
Day 1: Managing Internal Audits
- Critical role of quality audits in compliance & improvement
- Regulatory standards and guidelines for quality auditing
- GMP and QS requirements for internal audit programs
- Risk Assessment as it applies to quality audit practices
- Documents, records, and data for effective audits
- Audit schedules and the use of risk management in relation to prioritizing audits
- Techniques and tips for auditing - 6 fundamental steps of auditing
Day 2: Corrective and Preventive Action (CAPA) in Internal Audits
- What is Corrective and Preventive Action (CAPA)
- How to apply CAPA to quality audits
- How to apply Risk Management principles to:
- Audit observations
- CAPA
- Audit verification
Participants
This course is designed for operational personnel (key operators, supervisors, and managers) who have a key role in quality systems implementation and will assist them to develop a system of quality audit.
Training Grant is available under HRDF SBL Scheme
E-Certificates endorsed by the NPRA, Ministry of Health, Malaysia will be awarded to participants upon successful completion of the course.
Dates and Registration
Download the program brochure below for courses and dates. See pages 13 and 14 for registration.
Contact Details
Mike Lee
MOPI
Global Business & Convention Centre,
Mezzanine Floor, Block A, No 8, Jalan 19/1, Section 19,
46300 Petaling Jaya, Selangor, West Malaysia
Tel: +60 3 7931 9003
Fax: +60 3 7932 2730
E-mail: mike@mopi.org.my and admin@mopi.org.my
