Ex 122 - Internal Auditor Training for the Medical Industry complying with FDA and CE Marking Requirements (ISO 13485/9000 and QSR)


To introduce you to auditing as a powerful management tool in establishing how effective an organization is in controlling the quality variable. In addition to developing the techniques of internal auditing, an awareness of certification audits is provided to allow you to prepare for FDA/Notified Body audits.

Using lectures, practical and interactive workshops and simulated audits, this course provides the techniques needed to effectively perform comprehensive quality system audits that comply with all regulatory requirements.

Key Session Topics

  • Develop an effective quality management system
  • General audit principles and objectives
  • Audit objectives: identifying opportunities for change
  • Training and selecting the right people for the internal auditing team
  • Construct a quality system audit programme
  • Creating a system that people trust
  • Planning, scheduling and administering the audit programme
  • Developing checklists
  • Quality manual review process
  • Developing an audit report structure
  • Master effective auditing techniques
  • Interviewing and questioning personnel
  • Selecting samples for the review during the audit
  • Reviewing documents
  • Effectively documenting the findings
  • Workshop on auditing techniques
  • Acquire important strategies for performing a successful audit
  • Pre-audit meetings
  • Auditing for effectiveness
  • How to conclude the audit
  • What may go wrong
  • Evaluate the significance of audit findings
  • Improve communication skills during the audit presentation
  • Report the findings and evaluations
  • Implement quality improvement through the progression of corrective action programs

Who Should Attend

This course is intended for anyone who will be conducting Internal and Supplier Audits for medical device manufacturer under FDA and MDD/IVDD requirements.

Also those who will be subject to internal and third party audits including:

  • Design Engineering
  • Production Personnel
  • R&D
  • Quality and Regulatory Affairs
  • Management Representatives
  • Document Control
  • Sales/Marketing
  • Senior Management

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