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Secrets to Writing Effective SOPs for Medical Device QMS

Event Details

Secrets to Writing Effective SOPs for Medical Device QMS

Time: March 25, 2019 from 10am to 11:30am
Location: Online
Street: 161 Mission Falls Lane, Suite 216,
City/Town: Fremont
Website or Map: http://www.traininng.com/webi…
Phone: 18004479407
Event Type: webinar
Organized By: Joseph Wilcox
Latest Activity: Feb 11

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Event Description

Overview

Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed.

More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes and quality work.

This webinar will help you to write clear, unambiguous, and flexible SOPs. You will learn techniques for creating easy to read, clear, and concise SOPs that your employees can easily follow. Well written SOPs ensure that your employees understand and consistently follow processes. Well written SOPs send a message that your QMS is complete, accurate, and followed.

Why should you Attend

 "Inadequate SOP" observations still rank among the most frequently cited 483 and Warning Letter observations. SOPs are one of the first things an auditor/ investigator will review during and inspection. Most importantly, poorly written procedures make it difficult for your employees to understand and consistently follow procedures. This can lead to disastrous consequences including quality problems and even recalls. Poorly written SOPs can and do impact your business.

Areas Covered in the Session

  • FDA Expectations for SOPs
  • Lessons Learned from 483s and Warning Letters
  • Common Problems and Mistakes
  • How to Structure your QMS and SOPs
  • How to Outline and Format your SOPs
  • Using Process Maps to Make Procedures Clear
  • Using Diagrams and Visuals
  • Maintaining and Controlling SOPs
  • Ensuring Adequate Training to your SOPs
  • Best Practices

Who Will Benefit

  • Quality Systems Specialists
  • Document Control Specialists
  • Quality and Compliance Specialists
  • Internal Auditors and Managers
  • Training Specialists
  • CAPA Specialists
  • Quality/Compliance Managers or Directors for Medical Device Companies
  • General Managers Wanting to learn how to Understand Quality System Requirements
  • Subject Matter Experts

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.

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