This 90 minute Webinar will cover the concepts of measurement, analysis, and improvement to ensure conformity of products, conformity of the management system, and on-going effectiveness. This webinar includes strategies to improve the efficiency of your Quality Management System (QMS) for medical device companies. An effective yet efficient quality system can be a competitive advantage for companies by leading to improved quality and compliance as well as optimizing the cost of quality. This webinar will get you started in setting up just such a Quality System. We’ll discuss techniques for improving efficiency, reducing burden, and still maintain an effective QMS. In this webinar, we will discuss: – Regulatory Expectations – Common problems and lessons from 483 and warning letters – Red-flags that your QS is not effective – Measurement and metrics – Feedback, Complaint Handling, Internal Audit – Analysis of data – Risk based thinking – Improvement and your CAPA process – Management Review Why You Should Attend: This webinar will help you understand regulatory requirements and how to translate them into a quality system that is both effective and efficient. You’ll learn to recognize sources of ineffectiveness and inefficiency in your QMS. This webinar can help you get your quality system off to a good start and avoid common problems including MDRs, recalls, 483s, and warning letters! The expectations for quality and compliance continue to increase. We will discuss changing regulations and expectations and what you can do to prepare for them. This seminar will allow you to interact personally with an industry expert with over 30 years’ experience in medical devices. Learning Objectives: Quality System Expectations Characteristics of an effective QMS Characteristics of an efficient QMS Roles, responsibilities, capabilities Red Flags and warning signs Improvement tools and techniques Inspection preparedness and management Best Practices Areas Covered in the Session : 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 Who Should Attend: Quality Systems Specialists Document Control Specialists Quality and Compliance Specialists Auditors Auditor Managers Compliance Managers Quality Managers CAPA Specialists Quality and Compliance directors for Medical Device companies General Managers and Executives wanting to use Compliance and Quality as a competitive strength


$348 

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Areas Covered in the Session :

  • Review the current regulatory requirements and guidances (CFR, EU GMPs, ISO, etc.) for environmental monitoring.
  • Discuss issues of sampling methods, selection of sampling sites and the justifications for them.
  • Review the issue of contamination control as an important aspect of EM programs.
  • Discuss the issue of action and alert limits, trending of data and the handling of excursions.
  • What are the most common deficiencies cited by regulatory auditors when auditing environmental monitoring programs?
  • Attendee question and answer period.

Who Should Attend:

  • QA/QC Teams
  • Manufacturing Teams
  • Engineering Teams
  • Validation Teams
  • Regulatory affairs Teams
  • Management Teams
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