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Post Market Surveillance and Vigilance Requirements for Manufacturers (EU 2017/745)

NSF International, Pharmaceutical Services
Course summary
1 hour
299 USD excl. VAT
Online courses
Next available date: Inquire for more information - Online courses

Course description

Post Market Surveillance and Vigilance Requirements

Post-market surveillance for manufacturers is covered in Articles 83-86. Articles 87-89 cover post-market vigilance requirements. This course reviews the requirements set forth in these articles in detail, with expert advice provided throughout the course

Outcome / Qualification etc.

Certificate: By completing/passing this course, you will attain the certificate Medical Device Certificate

Training Course Content

By the end of this course you should be able to:

  • Recognize the layout and utility of specific sections, articles and annexes of the EU MDR.
  • Identify where manufacturers can locate detailed information on developing a post market surveillance system, plan and reports.
  • Identify where manufacturers can locate detailed information on vigilance requirements including the reporting of serious incidents and field safety corrective actions (FSCAs).
  • Recognize the responsibilities of manufacturers in trend reporting and analysis of serous incidents and FSCAs.

Why choose NSF International, Pharmaceutical Services

Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course

Provided expert pharmaceutical training for over 30 years

More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider

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About provider

NSF International provides a comprehensive range of independent, third-party pharmaceutical and biotech support services covering consulting, training, auditing and regulatory guidance for the pharmaceutical industry. These services are delivered by some of the most knowledgeable experts in their fields. Our unique...

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Contact info

NSF International, Pharmaceutical Services

The Georgian House, 22/24 West End
YO62 6AF York

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