ISO 22442-2 Medical Devices Utilising Animal Tissues or Derivatives
USD $70.00
Course duration: Allow 2 to 3 hours to complete this course.
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Description
An online training program to help Personnel and Regulatory Authorities understand compliance requirements relevant to the ISO 22442-2 (2020) standard: Medical Devices Utilizing Animal Tissues/Derivatives (requirements for sourcing, collection and handling).
FDA, EU MDRs, and ISO 22442-2 Medical Devices Compliance Training
This online course will help you understand risks and risk management requirements for sourcing, collection and handling of animal tissues or derivatives for use in medical devices. It is Part 2 of the ISO 22442 series of standards for these types of medical devices.
This course also includes insights and compliance requirements relevant to guidance or regulations from the US FDA, the Australian TGA, and the European Union (EU).
Standards and regulatory requirements for medical devices that utilise animal tissues or derivatives, discussed in this online Certificate course, include the following:
- ISO 22442-2 – Medical Devices Utilising Animal Tissues or Derivatives
- FDA Regulatory Guidance for Medical Device manufacturers that utilise animal tissues or derivatives in their medical device manufacturing processes or finished products.
- EU Medical Device Regulations (EU MDRs) and relevant regulations
ISO 22442-2 Medical Devices (Animal Tissues) Compliance – Course Duration
The course will take approximately 3 hours to complete.
Note: While this course will help you understand compliance requirements (in a plain language, multi-media/visually-enhanced format), the standard is available for purchase/licencing from ISO.org. Employees and manufacturers need to have a licenced copy, which can be purchased directly from ISO.
What you will learn in this ISO 22442-2 compliance training course
It provides learners with helpful resources pertaining to understanding the compliance requirements detailed in the ISO 22442-2 (2020) Part 2 standard relating to sourcing, collection and handling of animal tissues or derivatives to be utilised in medical devices.
Topics covered include:
- Types of medical devices that utilise animal-sourced tissues or derivatives
- Risks assessment and controls (elements of the overall quality management system)
- Transmissible disease risks (including TSE and BSE)
- Personnel requirements and risk controls during collection, handling, and transport
- Overview of key regulations for Medical Devices that utilise animal tissues or derivatives
- ISO 22442-2 (2020) Part 2 – Sourcing, Collection, and Handling
- FDA Guidance for Manufacturers
- EU MDRs and EU Regulation 722/2012
- Technical Agreements (inclusions)
- Relevant Guidance
It includes helpful information for Abattoir employees, Manufacturers, Quality Managers, Veterinarians, Regulatory Authority Personnel, Auditors, Compliance Inspectors, subcontractors, suppliers, and other stakeholders.
Medical Device Industry Guidance
- This is one of our many cGMP & Medical Device education topics in an eLearning format (available 24/7)
- While designed as a stand-alone course, ISO 13485 compliance training and ISO 14971 compliance training are additional courses for Manufacturers of Medical Devices, Industry Auditors, Regulatory Authority representatives, Notified Bodies, and facility Inspectors.
- This course is an ideal follow-up course to the online training course to learn to comply with ISO 13485:2016 requirements and ISO 14971.
- 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)
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”.
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 Duration:
Allow 2 to 3 hours to complete this eLearning training course including completing the online Final Assessment to gain your Course Certificate.
