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Process validation training activities with a product lifecycle management concept and the FDA risk management framework is critical for the medical device industry, because most of the device failures happen from inadequate processes and poor process control systems. Manufacturers of medical devices must meet the requirements of the Quality System regulation for medical devices (21 CFR part 820). The Quality System regulation at 21 CFR 820.5 states that “each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device manufactured

Proper quality control programs help to control or eliminate manufacturing defects. FDA also believes that incoming material and in-process control validations will assure high quality.

Why Should You Attend:

Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications. Too many processes and too many validations are likely to result in too much time and money wasted in addition to FDA warnings. This webinar teaches you how to minimize process controls and process validations.

Areas Covered in the Session:

  • FDA quality systems requirements
  • Requirements for design and development planning
  • Requirements for  process  inputs
  • Requirements for  process outputs
  • Requirements for  process design review
  • Requirements for  process verification
  • Requirements for  process validation
  • Packaging and labelling process controls
  • Requirements for  process changes
  • Maintenance and inspection of equipment
  • Control, use, and removal of manufacturing materials
  • Device master record

Learning Objectives:

  • Learn to minimize the need for process validation
  • Understand the principles of designing a robust process
  • Learn to look for advanced warnings of process going out of control
  • Learn how to prevent process defects for permanently

Who Will Benefit:

  • Senior management
  • All manufacturing/production managers
  • Manufacturing and production engineers
  • Manufacturing supervisors
  • Quality assurance staff
  • Regulatory affairs staff
  • Production operators



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