Production and Process Controls for Medical Devices

🎤  Susanne Manz        |  📅  Recording Available   |  🕒  90 Minutes

Areas Covered In The Session: Establishing P&PC Change Control Environmental Control Personnel Requirements Contamination Control Buildings Equipment Manufacturing Material Automated Processes Inspection, Measuring, and Test Equipment Process Validation Linkages to the total product life cycle and risk management Process Improvement

Production and Process Controls (P&PC) are one of the key capabilities necessary for medical device companies to consistently and effectively produce products. Because Production and Process Controls are so critical they are one of the major subsystems emphasized in inspections by the FDA.Failure to adequately implement Production and Process Controls (P&PC) can lead to disaster for your company… or even worse… for your customer. And P&PC continues to be a leading cause of 483 and warning letter observations from the FDA.Even more alarming, P&PC failures are a leading cause for complaints, malfunctions, and product recalls. This webinar can help you prevent serious issues such as these. You’ll learn about FDA quality system regulation expectations, and how you can successfully and efficiently establish these into your Quality Management System. Join us to learn the essentials of Production and Process Controls.

Learning Objectives:

• Overview of the Regulations
• FDA Expectations
• Lessons Learned and Common Mistakes
• Best Practices
• Preparing for an FDA Inspection

Who Should Attend:

• Auditors
• Quality Engineers
• Manufacturing Engineers
• Engineering Managers
• Manufacturing Supervisors
• Manufacturing/ Production /Operations Supervisors, Managers, and Directors
• Plant Managers
• Quality Managers
• Employees new to Medical Device Companies