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Medical Device SOP Writing and Process Mapping Training

In this class 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 European regulations, ISO 13485:2016, and FDA’s QSIT. The course goes beyond compliance by demonstrating that well-written standard operating procedures (SOP) reduce the potential for human error in processes. It also introduces concepts to assist in writing for the audience and designing procedures to reduce cognitive overload and mistakes.

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Brief Overview of This Class on Process Mapping and Writing Standard Operating Procedures

SkillsLab Class ?

Class Content

In-Depth

Class Duration

4 Half-Days*

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Certification of Completion

Yes

Continuing Education Units (CEU)

1.5

* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered over 2 consecutive days. 

** Interested in private training for your team, virtually or in person at your facility? See more details or ask us about it!

Upcoming Classes

Upcoming Medical Device Document Control Classes

SkillsLab $2195

There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!

GROUP DISCOUNT

Save up to

25%

Register 3 people, 4th attends free!

Free

*This offer cannot be combined with any other promotional offer(s).

Course Overview

Here's What We Cover in This Intensive SOP and Process Mapping Class

The document management system provides the objective evidence that organizations are taking a risk-based approach to process management and demonstrating change management that is linked to effective upstream and downstream QMS processes. This course will help organizations plan and improve their documentation control systems, gain compliance for electronic records and signatures, and prepare for audits. 

Course Overview
SkillsLab Class

Quality Management Sytems Standards and Regulations

  • Quality management system (QMS) review
  • QMS in ISO 13485:2016 and MDSAP
  • QMS in 21 CFR 820
  • QMS in EU Regulations (2017/745)
  • Problems and benefits

Documentation Structure and Regulations

  • Structure of a documentation system
  • ISO 13485:2016 Clause 4
  • FDA’s 21 CFR 820.40
  • EU technical documentation

Electronic Documents and Records

  • Identify software used for procedures and records in the QMS and their validation requirements
  • Understand the definition and regulation of electronic records and electronic signatures in 21 CFR Part 11

Documenting Processes

  • Review the requirements for process identification and management in ISO 13485 and MDSAP
  • Recognize the value of process mapping in documentation
  • Review tools and terminology for articulating processes
  • Evaluate process-mapping tools

Technical Writing and Good Documentation Practices

  • Discuss the three hallmarks of effective technical writing
  • Identify factors influencing readability
  • Discuss Good Documentation Practices (GDP) requirements

Error-Proofing Procedures - Designing and Training

  • Recognize the importance of designing processes and procedures to reduce human error
  • Explain effective training strategies to increase retention and minimize the need for retraining

Developing Documentation

  • Creating the quality manual
  • Quality plans and detail required
  • Procedure development
  • Suggested formats
  • Procedure practice
  • Planning instructions
  • Formats
  • Instruction practice

Change Control

  • How to maintain a compliant document management system
  • Change control for documents
  • Aligning changes to risk management, design control, and regulatory submissions

Preparing for Inspections and Audits

  • What to expect related to document control activities during:
    1. FDA inspections
    2. Notified Body audits
    3. MDSAP audits
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to
SkillsLab

Review the requirements of regulations and standards [ISO 13485, Medical Device Single Audit Program (MDSAP), FDA, and the EU Medical Device Regulation] as they relate to the quality management system (QMS).

Plan and structure a technical documentation system that complies with ISO 13485, MDSAP, FDA, and EU Medical Device Regulation requirements. 

Identify software used in QMS documentation and the associated regulation 21 CFR Part 11 (Electronic Records; Electronic Signatures). 

Apply process mapping to documentation practices to articulate process linkages in the QMS. 

Evaluate best practices in technical writing and Good Documentation Practices (GDP). 

Explain how documentation and training can reduce human error, decrease variation, and increase operational efficiency. 

Develop documentation, including mandatory and recommended elements for policies, procedures, and instructions. 

Develop a robust change control system linked to design and risk control activities. 

Describe best practices in preparing for successful outcomes from FDA, Notified Body, and MDSAP audits. 

Who Should Attend

Who Should Attend

Recommended for staff members involved in preparing plans, procedures, and instructions as part of a document management system. Especially valuable for those responsible for document maintenance and improvement, including management representatives and auditors, quality managers, operations managers, and process owners.

  • Quality Auditors and Managers
  • Document Control Specialists
  • Operations Managers
  • Process Owners
  • QMS Management Representatives

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