Writing good SOPs: meeting FDA expectations and avoiding 483s


Well-written SOPs send a message to the FDA and notified bodies that your Quality Management System (QMS) is complete, accurate, and followed and more importantly, it ensures that your personnel can consistently and accurately follow your processes, which results in correct outcomes and quality work. Our upcoming webinar discusses how to write complete, clear, unambiguous, and flexible SOPs that accomplish the objective and which your employees can understand and follow.
The webinar covers the following key areas:
·         FDA expectations for SOPs and lessons learned from 483s and warning letters
·         Using process maps to make procedures clear, and mistake proofing concepts
·         Maintaining and controlling SOPs
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 Profile:Susanne Manz is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has 30+ years of professional experience.
Use Promo Code SPRS20 and get flat 20% discount on all purchases.
To Register (or) for more details please click on this below link:
http://bit.ly/3828hdE
Email: support@trainingdoyens.com
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882
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