Production and Process Controls for Medical Device Companies
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.
May 6, 2020
10:00 AM PDT | 01:00 PM EDT
More Trainings by this Expert
Product Id : 502945
Live: One Dial-in One Attendee
Corporate Live: Any number of participants
Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
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 should you 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.
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.
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.
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.