MMD-110 Medical Device Single Audit Program (MDSAP) Internal Auditor Training
Training by
Ampro Solutions Sdn Bhd
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Details
The need for self-assessment is specified and achieved through internal auditing of the Quality Management System which aids regulatory compliance as well as identifies opportunities for improvement. This course is designed
to give participants familiar with ISO 13485:2016 the knowledge and skills needed to undertake an unbiased and constructive Quality Management System audit in line with the generic guidelines laid down in ISO 19011. Participants will learn the skills and techniques
of a process audit and how to communicate the findings so as to increase the effectiveness of the organisation’s management.
Participants will be led by an experienced trainer whom, in addition to being a CE Marking auditor, technical file reviewer and Quality Systems/ GMP auditor, has 3 decades of assessment, training and quality assurance as
well as management system development experience. Participants will engage in small group activities, lively debate and case studies, along with instructor led segments. Participants will learn how to apply these principles to produce effective internal audits
of medical device manufacturing in preparation for external audits by MDSAP Auditing Organisations.
Outline
The course covers tutorials, discussions, case study and facilitated activities on the following:
- MDSAP Auditing Approach
- Overview of Internal Auditing
- Pre-Audit Preparation
- Conducting the Audit
- Reporting the Audit
- Follow-up after the Audit
- Risk Based Approach in Internal Auditing
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Ampro believes that the key to a successful and rewarding career is continuous professional development. We have a flexible approach to your training needs with regardless of whatever your requirements, we promise you a high level of service with packages that meet the needs of your business.
As a forward thinking company we deliver training at all levels, thereby supporting your company at every stage of its development. Courses can be delivered onsite at a location of your choice, costs dependent upon location and numbers, or at hotel.
Our Company Values
We are determined in developing new programmes and staying on-point with industry's trend, while maintaining exceptional quality standards.
When we commit to something, we’re totally devoted. Whether it’s our dedication to our clients; or to maintain at the leading edge of training services we offer; we are always dedicated to our task.
Our People
All our staff are highly motivated professionals, experienced and qualified in their own specialist areas, who are committed to works towards common goals.
Our trainers and consultants are quality assure and have been tested on their ability to deliver top-quality programmes. ...
Our Company Values
We are determined in developing new programmes and staying on-point with industry's trend, while maintaining exceptional quality standards.
When we commit to something, we’re totally devoted. Whether it’s our dedication to our clients; or to maintain at the leading edge of training services we offer; we are always dedicated to our task.
Our People
All our staff are highly motivated professionals, experienced and qualified in their own specialist areas, who are committed to works towards common goals.
Our trainers and consultants are quality assure and have been tested on their ability to deliver top-quality programmes. ...
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