Process Validation for Medical Device, Pharmaceutical, and Combination Product Manufacturing

11. to 13. Mar 2019

Minneapolis, MN

This course will help you:

  • Fully understand the regulatory requirements for process validation and their relationship to the Medical Device QSR and the Pharmaceutical cGMPs
  • Gain knowledge to help manage a successful validation project
  • Fully understand and successfully interpret the GHTF/SG3/N99-10:2004 Guidance on Process Validation
  • Understand how to meet the new ISO-13485:2016 and ISO-9001:2015 validation requirements
  • Understand other applicable guidance documents and standards such as ISO-14971:2012, ICH-Q9, and FDA’s Process Validation: General Principles and Practices – 2011
  • Learn how to integrate design validation and process validation programs
  • Understand how to setup and run a complete validation program and master validation plan
  • Learn to write effective validation and qualification protocols
  • Learn how to qualify the installation and operation of process equipment
  • Learn to employ a risk based approach to process validation
  • Understand the connection between validation and the change control system of a quality management system
  • Learn how to determine critical process variables
  • Learn the requirements for validation reports and process deviations

Course Details

• 3 Days

• 2.3 CTUs

• $2295

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