2024 Changes to FDA 21 CFR 820: QMSR ISO 13485 Integration
Days: 0.5
Time: 7:30 AM- 11:30 AM MST
Audience: Beginner to Advanced
Overview
This half (1/2) day training will train you on revisions to the FDA 21 CFR 820 Management System Regulations (QMSR) published in February 2024, especially related to the integration of ISO 13485:2016.
You’ll receive an understanding of the following:
- The FDA’s announcement on February 2, 2024 to integrate ISO 13485:2016 into the new 21 CFR 820 QMSR
- New implementation timeline
- Real examples of what’s new, and what is being removed or becoming obsolete
- Examples of what is still required by FDA regulations until February 2026
- The importance of getting started RIGHT NOW to create the Quality Manual, etc.
- Medical Device Single Audit Model (MDSAP) and how impactful it can be to the QMS and audit program
Who Should Attend
- ALL companies who make a medical device regulated by the FDA (Class I, II and III)
- Top/Senior Management – Strategic Planners
- Regulatory Management – Strategic AND Tactical Planners
- Regulatory Associates – Tactical – “Doers” of the work
- Marketing Management – Strategic Planners and Post-Market Surveillance
- Quality Managers and Associates
- Auditors: Internal & 3rd Party external auditors
- Consultants advising clients on making the upgrades to the new QMSR
- Design and Development Engineers and Management
- Product Risk Managers
Objectives
- Understand the primary changes from QSR to the QMSR
- Understand the importance of creating a Quality Plan to effectively plan for the changes
- Identify the necessary steps as to prepare an organization to transition to the QMSR requirement
- The importance of MDSAP
Agenda
- High-level overview of the planned QMSR changes
- In-depth review of the planned QMSR changes
- Implementation timeline
- Strategy for deployment so the company’s QMS complies to the new QMSR regulation
- The importance of MDSAP
- Connecting with the appropriate Notified Body or Certification Body
Course Certificate
Participants will receive a cGMP 2024 Revision: FDA 21 CFR Part 820 QMSR Implementation training certificate.