OVERVIEW
Almost every paragraph of the Quality System Regulation says that manufacturers shall “establish” procedures. This webinar will help you to write complete, clear, unambiguous, and flexible SOPs 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 the SOPs ensure a result in more consistent process output and quality results.
LEARNING OBJECTIVES
Overview of the regulations
FDA expectations
Lessons learned and common mistakes
Best practices
Preparing for an FDA inspection
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 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
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
Should, Shall, May, Do Not, Guidance
Complete and concise
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 Engineers
Compliance Specialists
CAPA Managers
Complaint Handling Managers
Compliance Managers or Directors
Quality Managers or Directors
Process Owners
Business Leaders wishing to present a professional and compliant organization
SPEAKER
Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with an emphasis on quality, compliance, and six sigma. She has worked at industry leading companies such as GE, J&J, and Medtronic with an extensive background in quality and compliance for medical devices, including roles as Executive Business Consultant, Worldwide Director of Product Quality, and Director of Corporate Compliance.
Sussane is a Presidential Scholar with a BS in Biomedical Engineering and an MBA from the University of New Mexico. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and is a CQA (Certified Quality Auditor) from the American Society for Quality. She has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance. Her new book on Medical Device Quality Management Systems – Strategies and Techniques for Improved Efficiency and Effectiveness, is now available at Elsevier and Amazon.
Use Promo Code RSKPM and get flat 10% discount on all purchases
For more detail please click on this below link:
Email: webinar@247compliance.com
Toll Free: +1-510-868-1040
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