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

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.
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

LEARNING OBJECTIVES
• Overview of the regulations
• FDA expectations
• Lessons learned and common mistakes

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
To Register (or) for more details please click on this below link:
http://bit.ly/3bqBcer
Email: [email protected]
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882

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