America's Top Tradeshow Directory | Events In America
Facebook Linked In Twitter Videos

Event Contacts


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

Compliance Global Inc
(516) 900-5515

Event Description

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.

All information in Events In America is deemed to be accurate at the time we add it, and we take steps to verify all details and update our records when new information is provided, but as people, events and circumstances change, we caution users to independently confirm all information. EventsInAmerica.com and Events In America LLC make no guarantee of accuracy and assume no liability for inaccurate information.

Event Details

Website: http://bit.ly/2bvHEkP...
Conference/Event Dates: 10/06/2016 - 10/06/2016
Conference/Event Hours: 1:30
Classification: B2B
Primary Industry: Medical
Other Industries: Manufacturing, Medical
Cost to Attend: Live Session for one participant Price: $175.00
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
Show Owner:Compliance Global Inc.
Sponsorship: Yes
Sponsorship Details: Compliance Global Inc.

Booth Details

Booth Size Booth Cost   Available Amenities
No Exhibiting   Electricity: n/a
  Water: n/a
  Generator: n/a
  Marketing Vehicles Allowed: n/a
Other Booth Sizes Available: n/a

Advance Networking

How do I show up here?
 
Mark Travers

Personal Notes

Add a note here, it is only visible by you.

New Search Contact This Event