Webinar Information


Write it Right – How to Write SOPs that Employees Can Understand and Follow


Write it Right – How to Write SOPs that Employees Can Understand and Follow, Aurora, Colorado, United States
Webinar Title
Write it Right – How to Write SOPs that Employees Can Understand and Follow
Event Type
Webinar
Webinar Date
03-03-2020
Last Date for Applying
03-03-2020
Location
Aurora, Colorado, United States

Publish / Maintain / Marketing / Hosted By
Organization Name / Organize By
Training Doyens
Organizing/Related Departments
Life Science
Organization Type
Organization/Company
Webinar Category
Both (Technical & Non Technical)
Webinar Level
All (State/Province/Region, National & International)
Related Industries

Education/Teaching/Training/Development

Biotechnology

Manufacturing

Medical/Healthcare/Hospital

Location
Aurora, Colorado, United States

OVERVIEW

Almost every paragraph of the Quality System Regulation for medical devices says that manufacturers shall “establish” procedures. This webinar will help you to write complete, clear, unambiguous, and flexible SOPs (standard operating procedures) that accomplish that objective. You will learn techniques for creating concise and easy to read SOPs that your employees can understand and will follow. Well-written SOPs ensure consistent process output and quality results.
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 an FDA audit. 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

• FDA expectations for SOPs
• Lessons learned from 483s and warning letters
• Common problems and mistakes
• How to structure your QMS and SOPs
• How to write standard operating procedures and work instructions - outline and format of your SOPs
• Standard operating procedure checklist, outlines and formats
• Should, shall, may, do not, guidance
• Tips for complete and concise
• Using process maps to make procedures clear
• Using diagrams and visuals
• Mistake proofing concepts
• Maintaining and controlling SOPs
• Ensuring adequate training to your SOPs
• SOP best practices

LEARNING OBJECTIVES

• Overview of the regulations
• FDA expectations
• Lessons learned and common mistakes
• SOP best practices
• Preparing for an FDA audit

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

Susanne Manz 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. She has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson.

To Register (or) for more details please click on this below link:

http://bit.ly/39rn5Ux

Email: [email protected]

Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882

Others Details

Learn how to write standard operating procedures and work instructions in compliance with FDA regulations. The webinar also discusses how to prepare for an FDA audit.

Registration Fees
Available
Registration Fees Details
Live Session for one participant $159 Corporate Live Session Group – Max 10 Participants from one location. $449 Recorded Session Get unlimited access to the link for six months $199 Training DVD or USB Flash Drive MP3 files, PDF presentation and reference manual will be delivered on a CD $379 Super Combo Offer 1 Live and Recorded webinar $299 Super Combo Offer 2 Live and Training CD $429
Registration Ways
Email
Phone
Website
Other
Address/Venue
26468 E Walker Dr, Aurora, Colorado 80016-6104  Pin/Zip Code : 80016
Landmark
Colorado
Official Email ID
Contact
Training Doyens

26468 E Walker Dr, Aurora, Colorado 80016-6104

[email protected]

   Fax No: 80016
Training Doyens