MDSAP Fundamentals and Readiness - International

Poziom Zrozumienie Czas trwania 2 dni

Dostępne do rezerwacji: Wirtualne szkolenie prowadzone przez instruktora 5740zl + VAT Sprawdź terminy i ceny

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Gain the knowledge and skills required to successfully host a MDSAP audit within your organization.

Obtain in depth knowledge about this new type of audit and how your organization is best prepared to support the completing of requirements within the allotted time.
Discover how this program differs from the traditional ISO 13485 through its regulatory audit approach, the grading of nonconformities, and handling of the audit report. This course will prepare you to host a MDSAP audit and allow you to determine if your own internal QMS processes are consistent with the requirements of the MDSAP audit mode for the jurisdictions where your products are marketed.

Upon completion of this training, delegates will be able to support their organization to maintain compliance to ISO 13485 and jurisdiction requirements in the countries engaged in the MDSAP program.

How will I benefit?

This course will help you:

Improve auditing skills focused on regulatory auditing
Improve competence for MDSAP internal auditors and the support needed to host a MDSAP audit
Assess your own audit models and suggest improvement
Be prepared to support an efficient MDSAP audit by your selected Auditing Organization

On completion of this training, delegates will have the:

Knowledge to:
- Demonstrate awareness of MDSAP fundamentals
- Explain the structure and scope of the MDSAP audit program:
  
  MDSAP audit processes and their interrelationships
  
  MDSAP and organizational regulatory compliance
  
  MDSAP reporting and nonconformity grading
- Explain the differences between MDSAP and other QMS audits
  
  MDSAP and auditing in the medical device industry
  
  ISO 13485 and ISO 14971
- Identify MDSAP documentation
Skills to:
- Prepare to host a successful MDSAP audit:
  
  MDSAP 7 auditing process requirements
  
  Plan audit scopes
  
  Analyze data sources required during process audits
  
  Analyze control interactions
  
  Use correct jurisdictional terminology
- Quality Assurance and Regulatory Affairs professionals within medical device organizations currently active in participating territories and organizations expanding their market reach to jurisdictions participating in MDSAP.
Pre-requisites

Delegates will benefit from reviewing the MDSAP Companion Document and ISO 13485:2016 standard before attending this course.
- Detailed course notes
- Lunch
- Refreshments
- On completion, you'll be awarded an internationally recognized BSI Training Academy certificate
Download the Medical Device Single Audit Program (MDSAP) Fundamentals and Readiness Training Course Guide
Download the course flyer

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