MDSAP Training

Prepare for International Audits

Simplify Global Compliance with Our Internationally Recognized Training Program
Comprehensive Approach

Two essential modules in integrated training.

Experienced Instructors

Recognized experts in international regulatory compliance.

Recognized Certification

Globally accepted compliance readiness.

Module 1

RDC665/22 - Anvisa (National Health Surveillance Agency)

In this training you will learn:

Fundamental principles

Exploration of the essential principles behind the validation of analytical methods, understanding their importance in ensuring the quality and safety of products subject to health surveillance.

Validation Requirements

Details of the minimum requirements required for the validation of analytical methods as established by Anvisa Resolution RDC 665/22.

Validation Procedures

Practical guidance on the procedures and steps for validating analytical methods, including parameter selection, test protocols and data analysis.

Proper Documentation

Teaching about preparing the necessary documentation to prove the compliance of analytical methods, covering reports, records and essential information to be presented to Anvisa.

Applicability and Practical Context

Examples and case studies to illustrate the application of concepts learned in training, facilitating understanding and practical implementation in everyday professional life.

Reliability Guarantee

Emphasis on the importance of validating methods to ensure the reliability of analysis results, aiming for regulatory compliance and product safety.

We also offer: Consulting and Auditing.
Module 2

United States 21CRF820 - Food and Drug Administration - FDA

In this training you will learn:

Understanding Regulatory Requirements

Detailed exploration of the specific requirements set forth in the FDA's 21 CFR Part 820 for medical devices.

Practical Implementation of Good Manufacturing Practices (GMP)

Detailed guidance on how to apply Good Manufacturing Practice standards to ensure regulatory compliance.

Quality Control and Documentation for Compliance

Development of skills to create and maintain accurate documentation, essential to meet regulatory requirements.

Risk Management and Product Safety

Deepening the management of risks associated with the production of medical devices and the importance of product safety.

FDA Audits and Inspections

Comprehensive preparation to face regulatory audits and inspections, understanding how to respond and prepare for these assessments.

Practical Application with Case Studies

Use of real case studies to exemplify and apply the concepts learned in the context of the medical device industry.

We also offer: Consulting and Auditing.
Module 3

Canada SOR/98-282 and IMDRF

In this training you will learn:

Canadian Regulations SOR/98-282

Comprehensive details on Canada's specific regulatory requirements for medical devices, including the guidelines, standards and compliance processes established by SOR/98-282.

Understanding Canadian Medical Device Legislation

Detailed exploration of the fundamental principles and structure of Canadian legislation governing the development, manufacture and marketing of medical devices.

Practical Application of Canada Requirements

Practical guidance on how to effectively implement and comply with Canadian regulatory requirements in the development, production and distribution of medical devices.

Alignment with International Standards (IMDRF):

Connection between Canadian regulations and international standards established by the International Medical Device Regulatory Forum (IMDRF), understanding how these standards influence Canadian requirements.

Compliance and Certification Processes:

Details of conformity assessment processes, including the certification of medical devices, the criteria required for approval in the Canadian market, and the procedures to maintain compliance throughout the product life cycle.

Strategies for Success in the Canadian Market:

Strategic guidance to effectively navigate Canada's medical device market, addressing best practices, common challenges, and opportunities to ensure commercial success.

We also offer: Consulting and Auditing.
Module 4

Japan MHLW ordinance 169 PMDA

In this training you will learn:

Japanese Regulatory Framework:

Understanding of Japan's regulatory framework for medical devices, including the role and responsibilities of the MHLW and PMDA.

Ordinance 169 Requirements

Specific details on the requirements set out in MHLW Ordinance 169, including the guidelines for registration, manufacturing and marketing of medical devices in Japan.

Registration Process

Exploration of the medical device registration process in Japan, covering the necessary documents, deadlines, steps and requirements for approval.

Quality Standards

Understanding of quality standards required in Japan for medical devices, aligned with international standards and local expectations.

Post-Market Surveillance

Discussion of post-market responsibilities, including adverse event reporting, recalls and corrective actions in the Japanese market.

Challenges and Strategies

Identification of key challenges faced by companies in complying with Japanese regulatory requirements and strategies to ensure ongoing compliance.

We also offer: Consulting and Auditing.
Module 5

Australia TGA ARGMD

In this training you will learn:

Specific Regulatory Requirements

Detailed understanding of the requirements established by the TGA and ARGMD for the approval and commercialization of medical devices in their respective markets.

Registration Process

Knowledge of the specific process for registering and submitting medical devices to the TGA and ARGMD, including the necessary documentation and deadlines involved.

Quality and Safety Standards

Understanding the quality and safety standards required by these regulatory agencies, addressing technical and manufacturing aspects to ensure compliance.

Good Manufacturing Practices (GMP)

Exploration of Good Manufacturing Practice (GMP) guidelines and requirements established by the TGA and ARGMD, ensuring the safe and consistent production of medical devices.

Inspections and Audits

Knowledge of the practices and procedures involved in inspections and audits conducted by the TGA and ARGMD to assess the compliance of manufacturers and processes.

Compliance Strategies

Development of effective strategies to ensure ongoing compliance with TGA and ARGMD regulatory requirements, including change management and regulatory updates.

We also offer: Consulting and Auditing.
Lead Auditor

MDSAP - Medical Device Single Audit Program

In this training you will learn:

MDSAP Fundamentals

Understanding of the core principles and goals of the Medical Device Single Audit Program to ensure international compliance of medical devices.

International Regulatory Requirements

Mastery of the specific regulations of each participating country, such as the USA, Canada and Brazil, ensuring global compliance of medical devices.

Effective Audit Processes

Acquisition of essential skills and techniques to perform comprehensive and effective audits of medical device facilities.

Interpretation and Application of Standards

Ability to interpret and apply MDSAP standards accurately, following established guidelines to ensure regulatory compliance.

Risk Management and Non-Conformities

Proactive identification of risks and ability to deal with non-conformities, implementing corrective and preventive actions effectively.

Audit Communication and Documentation

Clear communication skills to report audit findings and document processes in a concise and understandable manner.

We also offer: Consulting and Auditing.

Participate in Our Training and Be Ready for Excellence in Quality.

Excellence in quality is essential for medical device manufacturers who want to succeed in the global market. MDSAP training is your best chance to achieve quality excellence and protect patient health and safety.

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Develop an effective quality management system
Implement safe and effective processes and procedures
Manage risks effectively
Produce safe and effective medical devices

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Questions about the MDSAP training

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What is MDSAP training?

MDSAP training is a training program offered by recognized auditing organizations (AOs) to prepare medical device manufacturers for MDSAP audits. The training covers the requirements of the Medical Device Single Audit Program (MDSAP), which is an international initiative led by medical device regulatory authorities (RAs) to simplify the audit process for manufacturers selling medical devices in multiple markets.

Who is MDSAP training recommended for?

MDSAP training is recommended for all medical device manufacturers who sell or intend to sell their products in markets participating in MDSAP. Training can help manufacturers understand MDSAP requirements, prepare for MDSAP audits, and improve compliance with regulatory requirements.

What is the format of MDSAP training?

MDSAP training can be carried out in open classes or in company (live online or in person)

What are the requirements to participate in MDSAP training?

Be certified as Lead Auditor 13485 by an Internationally Recognized Body.

How can I sign up for MDSAP training?

You can enroll for 1, 2 or more modules, to receive the MDSAP Lead Auditor certificate you must complete 1 Requirement module from the participating countries and the Audit Module.

Can I buy separate modules?

Yes, contact the Vesta Academy sales team.


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