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2018 - Secrets to Writing Effective SOPs for Medical Device QMS



VenueFremont, USA - United States USA - United States

KeywordsTraining Specialists; CAPA Specialists; Compliance Managers


Topics/Call fo Papers

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
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
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

Last modified: 2018-08-10 14:27:14