Internal Auditor Training for Medical Device Manufacturers
This course provides the theoretical segment of WMDO’s Internal Audit training program and describes in detail how to develop an effective and useful Internal Audit Program.
Learners will acquire the necessary knowledge on how to perform internal audits of a medical device manufacturer or third party quality system and related processes while taking into account the requirements of ISO 13485, the European Medical Device Directives and the associated sections of 21CFR820.
The course includes:
- Definitions and background that applies to Internal Auditing
- Regulatory and statutory framework of internal auditing
- The internal audit process and its functionalities as part of a management system
- Detailed outline of audit planning, audit preparation, audit conduct and audit follow-up
- Logical links within the quality system according to the subsystem structure defined by GHTF
- An outline of the requirements to become an internal auditor including necessary training and soft skills development
- Practical instructions for maintaining excellence and efficiency throughout all activities involved in internal auditing
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Upon completion of this course, trainees will be able to correctly and successfully:
- Comprehend and apply the statutory and regulatory requirements in the setup, management and execution of an internal auditing system
- Prepare and implement an efficient internal audit program
- Perform internal audits within the framework of your organization’s internal auditor qualification program.
This course is specifically designed for the following functions in the medical device industry: Professionals involved in internal auditing as quality managers, quality assurance assistants, manufacturing engineers, supply chain managers and purchasing officers; managers and officers involved in complaint handling and CAPA.
The course also targets any medical device professional in charge of ensuring compliance in his or her department and in need to learn all aspects of internal auditing and how it contributes to overall compliance within a department or throughout the company.
At least 5 years of experience in a medical device manufacturing environment, basic to advanced knowledge in the regulatory environment for medical devices, advanced knowledge in quality system environments for medical devices.