Writing and Enforcing Effective SOPs (Standard Operating Procedures)

  • Speaker:Susanne Manz
  • Duration:90Min
  • Product Code:GRC-90613

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Overview

Almost every paragraph of the Quality System Regulation says that manufacturers shall “establish” procedures”.  This webinar will help you to write clear, unambiguous, and flexible SOPs that accomplish that objective.  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.

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. 

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.

Learning Objectives

  • Overview of the Regulations
  • FDA Expectations
  • Lessons Learned and Common Mistakes
  • Best Practices
  • Preparing for an FDA Inspection

Topics:

This 90-minute webinar will include:

  • 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
  • Should, Shall, May, Do Not Guidance
  • FDA and overall global expectations and requirements for SOP development, implementation and enforcement
  • Using process maps to make procedures clear
  • Using diagrams and visuals
  • Maintaining and controlling SOPs
  • Ensuring adequate training to your SOPs
  • Best Practices
  • Understand the industry standards for procedure writing, including typical components of documents, and using document templates
  • Understand the full life cycle of SOPs
  • Understand how training is integral to document approval
  • Link SOPs to good documentation 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 who write procedures

Speaker Bio:

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.  While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, Worldwide Director of Quality Engineering, Worldwide Director of Design Quality, and Director of Corporate Compliance.   Susanne is a Presidential Scholar and has a BS in Biomedical Engineering and an MBA from the University of New Mexico.  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 is a Certified Quality Auditor by the American Society for Quality.  She has also served as a judge for the ASQ ITEA awards.  Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance. 

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Available Options

Live Meeting Access Single: Attend the Live Meeting Online from any location

$169

2 Single Live Access: 2 people can attend the meeting Live from any location

$249

Recording: Unlimited Viewing Access for 6 Months

$229

CD-DVD: Shipped within 2 working days

$279

USB - Shipped within 2 working days

$289

Live + Recording: Attend Live & Unlimited Viewing Access to Recording for 6 months

$269

Live + CD: Attend Live Meeting Online + Get the training CD shipped for free

$329

Live + USB - Attend Live online + Get the training USB shipped for free

$339

5 Member Group: 5 people can Attend the Live Online Meeting from any location globally

$469

10 Member Group: 10 people can Attend the Live Online Meeting from any location globally

$849

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