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Secrets to Writing Effective SOPs for Medical Device QMS


Overview: You will learn techniques for creating easy to read, clear, and concise SOPs that your employees can easily follow. Well written SOPs ensure that your employees understand and consistently follow processes. Well written SOPs send a message that your QMS is complete, accurate, and followed.

Why should you Attend:
SOPs are one of the first things an auditor/ investigator will review during and 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 in the Session:
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
Using Process Maps to Make Procedures Clear

Who Will Benefit:
Quality Systems Specialists
Document Control Specialists
Quality and Compliance Specialists
Internal Auditors and Managers
Training Specialists
CAPA Specialists

Speaker Profile:
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.

Event Fee: One Dial-in One Attendee Price: US $150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]

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