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

Production and Process Control: Building a Robust
System for Medical Device Companies
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

Instructor Profile:
Susanne Manz 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
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.

Description:
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.

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

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 can 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.
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Production and Process Control

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

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