Production and Process Controls for Medical Devices - By Compliance Global Inc

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

For more information, please visit : https://complianceglobal.us/product/700426/SusanneManz/production-and-process-controls-for-medical-devices/1

Email: support@complianceglobal.us 

Toll Free: +1-844-746-4244

Tel: +1-516-900-5515

Level: 

Intermediate

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. 

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.