Online Safety Community

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

Export to Outlook or iCal (.ics)

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.

Comment Wall

Comment

RSVP for Secrets to Writing Effective SOPs for Medical Device QMS to add comments!

Join Online Safety Community

Attending (1)

Take our poll!

Take our poll!

Latest Activity

Mark Nilson posted events
2 hours ago
Training Doyens posted an event
Thumbnail

Acquiring Pro-Skills in MS Office: Smart and Time Saving Techniques for EAs, PAs & Office Managers at 26468 E Walker Dr, Aurora, Colorado 80016

August 20, 2019 from 1pm to 2:30pm
OVERVIEWAs a basic-level user of Microsoft Office, you'd love to reduce the number of "hair-tearing-out" moments. You'd love to be able to do things faster so you can go home on time. You'd love to be seen as an “Office Hero” in your organization. As an added bonus, because Microsoft Office is so widely used across the globe, having good-to-excellent MS Office skills…See More
5 hours ago
Kelly Wilson posted a blog post

Public Liability Insurance Coverage Benefit to Landlords

Being a proprietor in today's times is no longer associated with high-end and upper class. Admit it; the whole idea of being a property owner no more is captivating. Gone are the days when property owners indicated people like Marquis Of Everemonde, that liked to gulp down chocolate when it was served by 4 servants. Today's property owners are those who own excellent apartments or flats and are ready to rent them out to travelers, pupils, newly wed pairs, immigrants and so forth. Land leasings…See More
23 hours ago
Mark Nilson posted events
yesterday

Forum

Workplace safety for workers other than your own 3 Replies

Do your workplace/traffic safety plans include safety measures for workers who are not your own employees? Do they take into account the safety of those who will be - or could be - at your workplace,…Continue

Tags: emt, paramedics, emergency, occupational, health

Started by John Petropoulos Memorial Fund. Last reply by Paul Lancaster May 28.

Imagine a technology which is an artificial muscle and is integrated into textiles...

Such a smart textile has huge application potential and can support people in many different ways. The garment would use haptic feedback (i.e. the use of touch to guide the user) or could serve as a…Continue

Started by Ulla Siegel May 28.

Green Smart Technical 800+ Turnkey Projects in UAE – Rope Access Company in Dubai

Green smart is an ISO 9001: 2015 QMS, OHSAS 18001: 2017 OHSMS, ISO 14001: …Continue

Tags: window, cleaning, services, facade, companies

Started by Manikandan Apr 23.

What % of Dollars should be bugeted for All Safety Training for a "Heavy Equipment Road Construction" company with 100 employees? 1 Reply

I have been at a Highway and Road Construction company for six months. I am developing a (first) complete training program. I am the 1st full time safety hire for this company. I need to develop a…Continue

Started by JTurpening. Last reply by Jen McDade Feb 19.

Technology and Safety 1 Reply

What are the most useful tools to have at your fingertips? -Toolbox Talks-JSA-JHA-Daily Reports, etc. What is falling through the cracks that could be an easy fix? Safety Managers, Coordinators and…Continue

Tags: safety

Started by Drew stone. Last reply by Jen McDade Feb 15.

Badge

Loading…

© 2019   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service