ISO 22442-2 Medical Devices Utilising Animal Tissues or Derivatives

Description

ISO 22442-2 Requirements & Compliance Training (online).

• This is an online regulatory compliance training program to help personnel and Regulatory Authorities/Inspectors understand compliance requirements relevant to the ISO 22442-2 (2020) standard: Medical Devices Utilizing Animal Tissues/Derivatives.
• This standard explains requirements for sourcing, collection and handling of animal tissues/derivatives used for medicinal products.

FDA, EU MDRs, and ISO 22442-2 Medical Devices Compliance Training

• This engaging, multimedia online course will help you understand the risks and regulatory requirements involved in the sourcing, collection, and handling of animal tissues or derivatives used in medical devices.

• It focuses on Part 2 of the ISO 22442 series, which outlines specific expectations for these types of products.

What’s Covered in the ISO 22442-2 compliance training course

• The course explains key elements of ISO 22442-2 (2020) in plain language, supported by visual aids and downloadable resources.
• It also includes relevant regulatory perspectives from:

  • U.S. FDA guidance

  • Australian TGA requirements

  • European Union MDRs and EU Regulation 722/2012

What you’ll learn by completing this ISO 22442-2 standards training course:

• Types of medical devices that use animal-derived materials

• Risk assessment and control measures

• Disease transmission risks (including TSE/BSE)

• Personnel, transport, and handling safeguards

• Overview of quality system elements and technical agreements

• Key compliance guidance and best practices

Who Will Benefit from this Course

• Medical device manufacturers and quality teams

• Veterinarians, auditors, and regulatory professionals

• Abattoir employees and subcontractors

• Suppliers and stakeholders involved in animal-sourced materials

Important Note – You must purchase the standard itself directly from ISO.org.

• While this course provides a strong foundation in ISO 22442-2 compliance, the official standard must be purchased from ISO.org.
• It’s essential that employees and organisations working in this area have access to a licensed copy of the full standard and that it is read in entirety either before and/or after taking this training course (depending on your learning preferences).

Medical Device Industry Guidance

• This is one of our many cGMP & Medical Device regulatory compliance education topics.
• It is available in a self-paced eLearning format (available 24/7) so long as you have reliable internet access.
• 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 Medical Device Regulations (EU MDR) Compliance Training (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 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”.
• Complete the online training and online Final Assessment (embedded in the course) to gain your Training Certificate for this topic.

---

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

• This training course is available fully online (24/7 access).
• One learner (user) per licence.