Production and Process Controls (P&PC) are one of the key capabilities necessary for medical device companies to consistently and effectively produce safe and effective products.
Because Production and Process Controls are so critical they are one of the major subsystems emphasized in inspections by the FDA.
Why you should Attend: 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.
Areas Covered in the Session:
- Establishing P&PC
- Change Control
- Environmental Control
- Personnel Requirements
- Contamination Control
- 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:
- Overview of the Regulations
- FDA Expectations
- Lessons Learned and Common Mistakes
- Best Practices
- Preparing for an FDA Inspection
- 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
Susanne Manz ,MBA, MBB, RAC, CQA 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. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance. Susanne has a BS in Biomedical Engineering and an MBA from the University of NM.