Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

Join us for a webinar on December 02 for a discussion of the webinar

Who will Benefit

  • Quality Systems Specialists
  • Document Control Specialists
  • Quality and Compliance Specialists
  • Internal Auditors and Managers
  • Training Specialists
  • CAPA Specialists
  • Supplier Quality Engineers and Auditors
  • Quality/Compliance managers or directors for Medical Device companies
  • General Managers wanting to learn how to understand Quality System requirements

Webinar Takeaway

This 90-minute webinar will focus on how to write clear, concise SOPs that your employees can follow. Topics to be covered include:

  • FDA and NB expectations for SOPs
  • Lessons Learned from 483s and warning letters
  • Common problems with SOPs
  • 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

Objectives of the Presentation

  • Understand QMS structure
  • Understand key elements of SOPs
  • Understand FDA expectations
  • Understand ways to make your SOPs more clear and easy to follow
  • Understand common problems and areas for improvement
  • Making your SOPs effective and efficient

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 structure your QMS and develop accurate, clear, unambiguous SOPs.

Why Should You Attend

"Inadequate SOP" is still one of the most frequently citied observations in FDA 483 and Warning Letter observations. Additionally, inaccurate, incorrect SOPs can lead to severe consequences and quality problems for your customers. This webinar will point out common errors in writing SOPs.

Medical Device Industry Expert

Susanne Manz ( 30+yrs exp.)

Medical Device Industry Expert


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, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance. Susanne has a BS in Biomedical Engineering and an MBA from the University of NM.

Choose a Purchase Options


$199

Live Webinar - Single Participant 90-mins

You get one log-in for the live 90-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email

$499

Group Up to 5 Participants ( MP3 Download Free )

You get 5 log-in for the live 90-minute webinar for all the participant, presentation materials , MP3 Download and the opportunity to ask questions by phone and email

$299

Recorded Access Corporate Group

You'll have access to group log-in for an archived recording of the entire 90-minute webinar, including the Q&A period, for 1 location. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

$389

MP3 Download - Training DVD

Within 48 hours delivered - Lifetime Access ,Audio recording of a webinar and reference manual delivered by download. Listen anytime on any compatible device.

$289

Live + Recorded Access - Single Participant

You get one log-in for the live & recorded 90-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email