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SOP Writing and Process Mapping for Medical Device Regulations
(ISO 13485, MDSAP and EU MDR 2017/745)

Documentation practices are evolving, so to avoid FDA or Notified Body findings you must stay ahead of the curve in this critical area.

Over 2 days you’ll learn best practices and strategies to plan and improve a documentation control system, gain compliance for electronic records and signatures, and prepare for audits under the new EU regulations, ISO 13485:2016, and FDA’s QSIT. The course goes beyond compliance by demonstrating that well-written procedures reduce the potential of human error in processes and introducing concepts in writing for the audience and designing procedures to reduce cognitive overload and mistakes.

This course is a good follow-up to our Quality Systems for Medical Devices: FDA’s QSR and ISO 13485:2016 class.

Upcoming Dates and Locations

Please Contact Us if you need additional information or if you don't see a date that works for you. To register by phone, call 1.888.532.6360  |  On-Site training available, learn more »

Location Start Date Days Cost Public Course On-Site
Orlando, FL 05/01/2019 2 $1995.00 Add to Cart CONTACT US
Edison, NJ 07/10/2019 2 $1995.00 Add to Cart CONTACT US
San Francisco Area, CA 08/22/2019 2 $1995.00 Add to Cart CONTACT US
San Diego, CA 10/02/2019 2 $1995.00 Add to Cart CONTACT US
Boston, MA 11/13/2019 2 $1995.00 Add to Cart CONTACT US

Objectives

  • Describe the requirements of regulations and standards (FDA, EU Device regulation and ISO 13485) as they relate to document control.
  • Plan and structure a document management system that meets new requirements for EU Technical Documentation
  • Identify software used in QMS documentation and regulation of electronic records and electronic signatures in 21 CFR Part 11
  • Apply process mapping to documentation practices to articulate process linkages for MDSAP
  • Evaluate best practices in technical writing and Good Documentation Practices
  • Review the basics in documentation, including mandatory and recommended elements for policies, procedures, and instructions
  • Develop a robust change control system linked to your design and risk control activities
  • Describe best practices in preparing for successful outcomes from FDA, notified body and MDSAP audits.

Topics

  • Documentation requirements (global regulations and standards)
  • Technical writing, process mapping, and error proofing
  • Electronic records
  • Change control requirements

Who Should Attend

Recommended for staff members involved in preparing plans, procedures, and instructions as part of a document management system.

Number of Days: 2
CEUs: 1.5
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