Quality Performance Improvement
This training is designed to provide basic understanding on cGMP with establish strong quality management systems that assure proper design, monitoring and control of manufacturing processes and facilities in regulations enforced by the Food and Drug Administration (FDA).
This training course provides basic understanding on Current Good Manufacturing Practice (cGMP) regulations enforced by the Food and Drug Administration (FDA). cGMPs establish strong quality management systems that assure proper design, monitoring and control of manufacturing processes and facilities. This course provides a complete overview of the industry requirements as specified by the FDA.
By the end of the training, participants would be able to:
- Describe what cGMPs are and why they are required
- Develop basic knowledge of 21 CFR Part 820
- Identify the consequences of noncompliance and benefits of compliance
- Demonstrate a personnel commitment to quality and compliance
2 days (9.00am to 5.00pm) or duration proposed at quotation.
Training session includes classroom lecture, exercises, group work and discussion.
All personnel within the organization who is expected to understand the cGMP and the benefits of compliance. This course also suitable for beginners and those embarking to understand and implement cGMPs. For Business owner, top management, managers, executives, supervisors, Team Leaders, engineers and technicians.
- Introduction to cGMP
- Overview and introduction to 15 subpart of 21 CFR Part 820:
- Quality System Requirements
- Design Controls
- Purchasing Controls
- Identification and Traceability
- Production and Process Controls
- Acceptance Activities
- Nonconforming Product
- Corrective and Preventive Action
- Labeling and Packaging
- Handling, Storage, Distribution and Installation
- Statistical Techniques
- Documentation and Records
- Benefits of Compliance
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.