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EVENT DATE
Oct 2016
M T W T F S S
03040506070809
EXPO DATE
Oct 2016
M T W T F S S
03040506070809

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Online Event
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Type: Online Event

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Secrets to Writing Effective SOPs for Medical Device QMS - By Compliance Global Inc.

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Overview:

Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.   

Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed. More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes and quality work.  

Well written SOPs ensure that your employees understand and consistently follow processes.

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 and inspection.

Areas Covered in this Webinar:

  • 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
  • Using diagrams and visuals
  • Maintaining and controlling SOPs
  • Ensuring adequate training to your SOPs

Learning Objectives:

  • Overview of the regulations
  • FDA expectations
  • Lessons Learned and common mistakes
  • Best Practices
  • Preparing for FDA Inspections

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

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. 

Susanne has a BS in Biomedical Engineering and an MBA from the University of NM. 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 Certified Quality Auditor (CQA) certification from the American Society for Quality.  

For more detail please click on this below link:

http://bit.ly/2bvHEkP

Email: referrals@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515

Fax: +1-516-900-5510

Not sure if you want to exhibit at or attend the Secrets to Writing Effective SOPs for Medical Device QMS - By Compliance Global Inc.? See the panels below to get the information you need to make an informed decision.

EVENT CONTACTS


Compliance Global Inc
2754 80th Avenue
New Hyde Park, NY 11040
(516) 900-5515

Compliance Global Inc
(516) 900-5515

EVENT DETAILS

Primary Industry:
Medical
Other Industries:
Manufacturing, Medical
Audience:
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
Notes:
Attendee Statistics:
Show Owner:
Compliance Global Inc.
Sponsorship: Yes

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