MY | MDSAP (Medical Device Single Audit Program) Training

Language : English

Please choose a date from the options below					Please choose a date from the options below	Location	Price
On demand Klang Valley	Klang Valley		Book

The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer's quality management system that satisfies the requirements of multiple regulatory jurisdictions.

The training provides:

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
Skills to Identify MDSAP documentation
Prepare to host a successful MDSAP audit:
MDSAP 7 auditing process requirements
Plan audit scopes
Analyse data sources required during process audits
Analyse control interactions
Use correct jurisdictional terminology

FOR WHOM:

This course is designed for anyone who may involve in the implementation and execution of this Quality System Regulation, e.g. top management, manager or project member in QM/QA, R&D, design, manufacturing, supply chain, customer service and sales. Knowledge about quality management system for Medical Device Industry (ISO 13485:2016) would be beneficial.

Agenda

Module 1: MDSAP Companion document - Chapter 1 management

Correspondence with ISO 13485 various Clause eg: 4 – 6, 7.2, 8.2.4;

Understanding the country specific regulatory requirement and expectation;

Q & A session

Module 2: MDSAP Companion document - Chapter 2 Device Marketing Authorization and Facility Registration

Correspondence with ISO 13485 various Clause eg: 4.1.1, 4.2.1, 5.2, 7.2.1, 7.2.3;

Understanding the regulatory requirement and expectation;

Q & A session.

Module 3: MDSAP Companion document - Chapter 3 Measurement, Analysis and Improvement

Correspondence with ISO 13485 various Clause eg: 4.2.1, 8.1, 8.2.1, 8.2.6, 8.5;

Understanding the regulatory requirement and expectation.

Module 4: MDSAP Companion document - Chapter 4 Medical Device Adverse Events and Advisory Notices Reporting.

Correspondence with ISO 13485 various Clause eg: 4.2.1, 7.2.3, 8.2.2, 8.2.3;

Understanding the regulatory requirement and expectation;

Q & A session

Module 5: MDSAP Companion document - Chapter 5 Design and Development

Correspondence with ISO 13485 various Clause eg: 7.3;

Understanding the country specific regulatory requirement and expectation

Q & A session

Module 6: MDSAP Companion document - Chapter 6 Production and Service Controls

Correspondence with ISO 13485 various Clause eg: 7.5, 7.6;

Understanding the country specific regulatory requirement and expectation.

Q & A session

Module 7: MDSAP Companion document - Chapter 7 Purchasing

Correspondence with ISO 13485 various Clause eg: 7.4;

Understanding the country specific regulatory requirement and expectation;

Q & A session