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EVENT DATE
Jun 2016
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Production and Process Controls for Medical Devices - By Compliance Global Inc.

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Overview

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.

For more detail please click on this below link:

http://bit.ly/1XV2gXv

Email: referrals@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515

Fax: +1-516-900-5510

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