Production and Process Control: Building a Robust System for Medical Device Companies

Duration: 90 Minutes
Production and Process Controls (P&PC) are one of the key capabilities necessary for medical device companies to consistently and effectively produce products. P&PC is critical to producing safe and effective products for your customers. It is a broad area covering environmental, personnel, contamination, building, equipment, inspection, materials, and more. Because of its criticality, P&PC is one of areas most closely inspected by the FDA. This webinar will help you understand what is necessary for P&PC and how to integrate it seamlessly with the rest of your Quality Management System.
Production and Process Controls
Instructor: Susanne Manz
Product ID: 501676
Objectives of the Presentation
This webinar will cover:
  • Overview of the regulations
  • FDA expectations
  • Lessons learned and common mistakes
  • Best practices
  • Preparing for an FDA inspection
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 customers. P&PC continues to be a leading cause of 483 and warning letter observations from the FDA.

P&PC failures are a leading cause for scrap, rework, re-inspection, low yields, low throughput and other manufacturing issues. More importantly P&PC failures can be a cause of 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. Turn P&PC into a competitive strength for your company.

Areas Covered
This webinar will cover:
  • 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
  • Installation procedures including inspection and testing
  • Important linkages to other QMS requirements
Who will Benefit
  • QMS Auditors
  • Quality Engineers
  • Manufacturing Engineers
  • Manufacturing Supervisors
  • Manufacturing/ Production /Operations Supervisors, Managers, and Directors
  • Plant Managers
  • Quality Managers
  • Employees new to Medical Device Companies
$375
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
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 worked at industry leading companies such as GE, J&J, and Medtronic with an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She is a Presidential Scholar with a BS in Biomedical Engineering and an MBA from the University of New Mexico. 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 is a CQA (Certified Quality Auditor) 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.

Susanne's new book on Medical Device Quality Management Systems - Strategies and Techniques for Improved Efficiency and Effectiveness, is now available on Elsevier and Amazon.
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