Understanding of FDA 21 CFR Part 820 - Quality System Regulation

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Looking to enhance your knowledge of FDA 21 CFR Part 820 - Quality System Regulation in Malaysia? Look no further than Inspiring Training & Consultancy PLT. Our comprehensive training program is HRDC certified, ensuring that you receive top-notch education and skills development in this crucial area of regulatory compliance.

Our expert trainers will guide you through all aspects of FDA 21 CFR Part 820, providing you with the knowledge and tools needed to ensure quality and compliance within your organization. Request a quote today to learn more about how our training program can benefit you and your team. Don't miss out on this opportunity to advance your understanding of FDA regulations and take your compliance efforts to the next level with Inspiring Training & Consultancy PLT.
Learning Objectives

1. Gain a comprehensive understanding of the FDA 21 CFR Part 820 - Quality System Regulation, including its purpose, scope, and key requirements. Participants will learn how this regulation applies to medical device manufacturers and the importance of compliance in ensuring product safety and efficacy.

2. Develop the ability to interpret and apply the requirements of FDA 21 CFR Part 820 in a practical setting. Through case studies and real-world examples, participants will learn how to implement quality management systems that meet the standards set forth in the regulation, including documentation, quality control, and risk management.

3. Enhance knowledge of FDA inspection processes and best practices for preparing for and responding to FDA audits. Participants will learn how to effectively communicate with FDA inspectors, maintain compliance with regulatory requirements, and address any findings or observations identified during an inspection. This will help ensure that the organization is well-prepared to demonstrate compliance with FDA regulations and maintain a strong quality management system.

Content Delivery Method

Physical, Virtual

HRD Corp Certified Course


Duration and Language

1 to 2 days; English

Target Audience

Suitable for employees of all levels

Key Skillset Addressed

1. Compliance knowledge
2. Quality system implementation
3. Regulatory understanding