This Event has Passed
Thursday, June 30, 2016
1:00 PM - 2:00 PM
1:00 PM - 2:00 PM See all dates and Times
https://complianceglobal.us/product/700426/SusanneManz/production-and-process-controls-for-medical-devices/1
Overview : Production and Process Controls (P&PC) are one of the key capabilities necessary for medical device companies to consistently and effectively produce products.
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. 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.
Areas Covered in this Webinar :
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
Learning Objectives :
Overview of the Regulations
FDA Expectations
Lessons Learned and Common Mistakes
Best Practices
Preparing for an FDA Inspection
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
Speaker 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 an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities.
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. 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.
Areas Covered in this Webinar :
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
Learning Objectives :
Overview of the Regulations
FDA Expectations
Lessons Learned and Common Mistakes
Best Practices
Preparing for an FDA Inspection
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
Speaker 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 an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities.
