MMD-115    Internal Auditor Training based on US FDA CFR Title 21 Part 820 

• Overview
• Course Objectives
• Course Content
• For Whom
• Schedule and Hours

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US FDA Internal Auditor Training is designed to provide participants with the knowledge on medical device market access into the Union. Personnel responsible for quality systems for medical device manufacturers will benefit from this course. Participants will gain an overview of the requirements of the CE Marking approach and the EU Medical Device Regulations as well as the key differences from the EU Medical Device Directive.

​Participants will be led by an experienced trainer who, in addition to being a Product Assessor and CE Marking auditor, has three decades of assessment, training, and quality assurance as well as management system development experience. Participants will engage in lectures including exercises in harmonizing these requirements and those of the IMDRF with respect to medical devices regulatory compliance as well as failures encountered by manufacturers in attempting conformity assessment.

Upon completion this programme, participants are able to:

• Understand US FDA regulations and their impact on internal audits.
• Learn the principles and best practices of internal auditing.
• Develop risk-based audit plans and conduct internal audits effectively.
• Identify non-conformances and recommend corrective actions.
• Apply audit techniques through a live audit session.
• Improve documentation and reporting for regulatory compliance.
• Enhance organizational compliance and continuous improvement efforts.

• Module 1: Introduction to US FDA Regulations
• Module 2: Internal Auditing Fundamentals
  
• Session 3: Internal Audit Planning & Preparation
  
• Session 4: Conducting an Internal Audit (Audit Execution)
  
• Session 5: Identifying & Documenting Non-Conformances
  
• Session 6: Corrective & Preventive Actions (CAPA) & Audit Follow-Up
  
• ​Session 7: Case Studies, Mock Audit & Q&A Session
  

This course is designed for :

• This training is ideal for Quality Assurance (QA) and Quality Control (QC) Personnel, Regulatory Affairs Specialists, Internal Auditors & Compliance Officers, Manufacturing and Operations Managers, R&D and Production Teams, and Any personnel responsible for FDA regulatory compliance.

This is a ​2 days programme.
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This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
 
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.

We are HRD Corp (Human Resource Development Corporation) Registered Training Provider.
​All of our training modules are claimable under HRD Corp.