Production and Process Controls for Medical Devices

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

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

Who Will Benefit:

• 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

Course Director: Susanne Manz

Susanne Manz is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.