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. She has a BS in Biomedical Engineerin Read more
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.
Course Objectives:
• Overview of the Regulations
• FDA Expectations
• Lessons Learned and Common Mistakes
• Best Practices
• Preparing for an FDA Inspection
Course Outline:
• 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
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
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
6-Hour Virtual Seminar on Computer System Validation for Cloud and COTS Applications
LIVE : Scheduled on
17-May-2024 :11:00 AM EDT
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2-hr Virtual Seminar: FDA Inspections - Understanding the Core Elements
LIVE : Scheduled on
20-May-2024 :01:00 PM EDT
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21 CFR 58 - Good Laboratory Practice (GLP) and USP 1058 Validations
LIVE : Scheduled on
30-May-2024 :01:00 PM EDT
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6-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?
LIVE : Scheduled on
18-June-2024 :11:00 AM EDT
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6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
LIVE : Scheduled on
19-June-2024 :11:00 AM EDT
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