Process Validation Training for Medical Devices

Introduction to Process Validation Training for Medical Devices

medical device validation trainingInzinc Training Solutions provide customized Training course on Process Validation for Medical Devices in India that helps Medical Device manufacturing Organizations to conduct Process validation for those processes that cannot be verified by subsequent monitoring and measurement.

Learning objectives of the training

  • General Suggestions to manage the Process validation required for the Organisation.
  • Understanding process validation as a regulatory requirement.
  • Tool to improve overall quality, eliminate scrap, reduce costs, improve customer satisfaction.

Audience

Following are the type of personnel who would be the right audience to take this training:

  • Quality Professionals and Management Representatives from medical device manufacturers
  • Individual Process Owners of the Organisation
  • Top Management

Brief topics covered in the training

Following topics are covered in this training session:

  • What is Process Validation
  • Decision to perform Process Validation
  • Select methods and tools for validation
  • Protocol development
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Change Management
  • Requirement for Revalidation
  • Examples of IQ, OQ and PQ

Duration of the training

The duration of training is 3 hours excluding the half an hour post training evaluation test for trainees

Mode of the training

Remote online training with live Presentation and demonstration of examples

Faculty for the training

Experienced tutor with rich experience in Medical Devices and Pharmaceutical fields

Trainee Evaluation

Trainees will be given a simple test of half an hour on the training topics. These may be mostly objective based with very few descriptive writing. 

Certification

Candidates will be awarded soft copy certificates within 1 working day after the course subjected to passing a half-an-hour simple test on training topics.

Study Material

Candidates will be provided with soft copy slide notes on the above topic.

Fill up the training registration form below and submit the details to enable us to provide you with an offer.


Training Registration Form

Back to our Training Home page

If you are interested in Medical Devices Consulting as per ISO 13485 Standard, please follow the below link: