MDSAP Training – Medical Device Single Audit Program

Description

MDSAP was launched by the IMDRF and its original participating members, including the US FDA, the Australian TGA, ANVISA in Brazil, Health Canada, and shortly afterwards, Japan’s Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA).

MDSAP update (2023)

The MDSAP program was last updated in March 2023 (effective 1 April 2023). Refer to the IMDRF Policy Title: MDSAP AUDIT APPROACH, Document No: MDSAP AU P0002.008 Revision Date: 2023-04-01).

MDSAP – Medical Device Single Audit Program (Training & FAQs)

This online course will help you better understand MDSAP (Medical Device Single Audit Program) and the MDSAP Audit Approach (AU P0002.008, Rev. Date 2023-04-02) including the many guidelines you will need to familiarise yourself with, the MDSAP Audit Policy document, and the MDSAP non-conformity grading system.

Topics covered in this eLearning course include:

• What’s required for participation in the MDSAP program?
• What do the 3 levels of participation actually mean (Member, Official Observer, and Affiliate Member)?
• Which jurisdictions/Regulatory Authorities accept MDSAP Audit reports?
• What are the roles and responsibilities of Regulatory Authorities vs Auditing Organisations (AOs)?
• What does the scope of an MDSAP Audit contain?
• How long does an MDSAP Audit take (MDSAP audit duration)?
• What is a Surveillance Audit in the MDSAP?
• How often do Surveillance Audits need to occur in the MDSAP (Medical Device Single Audit Program)?
• What’s the audit process and the nonconformity grading system for MDSAP participants like, compared to ISO 13485:2016 QMS audits?

Click here for other Medical Device Regulatory Compliance Training Courses.

For the full list of over 70 industry-specific courses, click here.

MDSAP Training, ISO 13485 and Other Regulatory Compliance Courses

This product is a Certificate Course covering MDSAP requirements and Regulatory Compliance expectations. It will assist Inspectors/Regulatory Authority Representatives, manufacturers, and distributors participating in the Medical Device Single Audit Program (MDSAP).

This course provides learners with a helpful resource pertaining to MDSAP audits for medical device manufacturers, with examples and resources from:

• IMDRF – International Medical Device Regulatory Forum 
• US FDA MDSAP pages
• Australian TGA MDSAP pages
• Health Canada
• ANVISA Brazil
• Japan

It includes helpful MDSAP guidance information for Manufacturers, Management, Regulatory Authority Personnel, Medical Device Industry Quality Personnel, and Auditing Organisations (AOs) who are seeking recognition/approval by IMDRF to conduct MDSAP audits.

Allow 2 to 3 hours to complete this course including the Final Assessment for your MDSAP training course certificate.

MDSAP Guidance for Medical Device Manufacturers & Regulatory Authorities

About this interactive online course overviewing MDSAP (Medical Device Single Audit Program)

This is one of our many Medical Device and GMP education topics available in an eLearning format (accessible 24/7) after purchase.

• While this MDSAP course can be completed as a stand-alone course, ISO 13485 training is also useful for Manufacturers of Medical Devices and Auditors/Inspectors who are assessing compliance.
• This course is an ideal follow-up course to the online training course to learn to comply with ISO 13485:2016 requirements
• It is a complimentary course to our other medical device regulatory compliance training courses including the EU MDR training course (online)
• Click here for a list of face-to-face courses delivered via Zoom, including CAPA (onsite training of large groups of personnel may also be available, where feasible)

Who should take this Medical Device Regulatory Compliance & MDSAP Auditing Training Course?

Medical Device Manufacturers participating in MDSAP

• This course is suitable for a wide range of personnel and management roles at the manufacturer level.
• It is suitable for manufacturing companies currently participating in MDSAP and for companies investigating MDSAP participation requirements.
• This MDSAP training presentation includes IMDFR MDSAP information, FDA MDSAP guidance, MDSAP participation requirements, MDSAP membership application links, and more.

Regulatory Authorities of Countries Participating in MDSAP

The course is also suitable for Regulatory Authorities and Auditing Organisations (AOs) and other auditors working in the Medical Device sector and/or medical device export industry.

While completing this course is helpful to understand MDSAP participation requirements and expectations, learners still need to download and read all applicable regulations and standards, e.g.:

• ISO 13485:2016 – Quality Management Systems for Medical Devices
• ISO 14971:2019 – Medical Device Risk Management
• MDSAP Audit Policy Title: MDSAP AUDIT APPROACH, Document No: MDSAP AU P0002.008 Revision Date: 2023-04-01.
• Auditing Organisation Recognition and Approval Process Policies and Forms
• Other relevant publications/guidance documents

Explore the online GMP special training bundles (combined training packages).

Purchasing several courses at one time helps you save on your training budget. Alternatively, you can purchase a single course, or just a few of the courses you need, to engage in ‘just in time’ learning.

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Note: All course prices are in US dollars ($35 USD is equivalent to approximately $55 AUD).

Bundled training options let you ‘mix and match’ standard GMP compliance training courses and/or assign courses to different employees when required (enabling ‘just in time’ GMP training). All successfully completed courses provide learners with a time-dated GMP Training Certificate for successful completion of that particular GMP education topic.

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About this Medical Device Industry Regulatory Compliance/MDSAP Audits training course

• Completion of any of our Medical Device Regulatory Compliance training courses and online cGMP training courses will enable you to print your  regulatory compliance education Course Certificate for that topic (e.g., GMP/MDR/MDSAP training certificates)
• Select courses also enable you to earn a Credly badge for your social media channels (not all courses include a Credly badge, yet all courses give you a printable Certificate of Completion for framing and for your personnel records).
• You can also attach your MDSAP Certificate of Completion to your CV when applying for new job openings in the medical device/life sciences sectors.

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Review other top-ranked Medical Device Regulations/MDR, ISO compliance training, and best-practice cGMP training courses, all online.

How to complete this course.

• Add the online MDSAP Training course to your basket
• Complete your purchase online using a credit card
• Remember, course fees are listed in US Dollars
• Check your emails (all folders) for log-in instructions approximately 5 to 10 minutes after your order is finalised
• Be sure to search for/add the following domains to your safe sender’s list: “@onlinegmptraining.com” and @pharmout.net”.

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One user/per licence purchase (12 months’ access)

• This MDSAP training course is available fully online (24/7 access).
• One learner (user) per licence.
• Course completion provides learners with a foundational understanding of the key elements of the MDSAP/Medical Device Single Audit program and auditing requirements for AOs, including reporting time frames and a list of the tasks required for an MDSAP Audit

Do you need to train your personnel to comply with Regulatory Compliance requirements?

• If you need to train large numbers of employees (e.g. 50 to 1000 employees, or more), contact us for a custom quote.
• You can alternatively order discounted GMP education topics/GMP training bundles.
• If you’re purchasing this course for yourself and your future career in the pharmaceutical industry, consider the customisable 4-bundle course packages.