/Dev  /Rahejaspeaker of compliance global
Speaker: Dev Raheja

Duration: 60 Minutes
Product Code: 700054
Level: Beginner

Process Validation with a Product Lifecycle Concept to Meet FDA Requirements

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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 this Webinar

  • 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

Speaker Profile

Dev Raheja, MS,CSP, is an international Risk Management and Quality Assurance consultant for Healthcare, medical device, and aerospace industry for over 25 years. He applies evidence base safety techniques from a variety of industries to healthcare. He is a trainer, author of the books Safer Hospital Care, and Preventing Medical Device Recalls. He shows clients how to come up with elegant solutions using creativity and innovation. He helped a major Midwest company from going out of business to becoming a world leader by eliminating safety mishaps. Prior to becoming a consultant in 1982 he worked at GE Healthcare as Supervisor of Quality Assurance and Manager of Manufacturing, and at Booz-Allen & Hamilton as Risk Management consultant for nuclear and mass transportation industry.

Currently he is an Adjunct Professor at the Florida Tech for its degree in Healthcare Management, and serves on the Patients and Families Advisory Council at Johns Hopkins Hospital. He is Associate Editor for Healthcare Safety for the Journal of System Safety, and is a member of the American College of Healthcare Executives.

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Product ID:700054
Duration: 60 Minutes

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