Medical Device Single Audit Program (MDSAP) – Part 2
Description:
According to the Audit Model, the manufacturer must be able to map all processes, their links, and the ISO 13485 clause relating to them, and compare to the company processes and Standard Operating Procedures (SOPs), Quality Manual etc. This course will discuss this Audit Model further and the Best Industry Practices for organizing, training, and remediation of company processes and the quality management system.
Curriculum for this course:
Introduction
Overview | 45 secs |
Learning objectives | 1 min |
Who should take this course? | 30 secs |
Terms explained | 1 min 15 secs |
Course modules | 35 sec |
Module 3: Preparing for MDSAP Audit Process
Audit Criteria Built Into IMDRF Audit Model | 1 min 05 sec |
The MDSAP Audit and Preparation | 1 min 15 se |
Manufacturers Guide to prepare for MDSAP | 55 secs |
Where to Begin Preparation | 1 min 30 sec |
Preparing for MDSAP: Ensuring Consistency | 1 min 23 s |
Sterile Medical Device Requirements | 1 min 15 sec |
QMS: Deciding Which Processes Will Be Audited | 1 min 30 secs |
How to Prepare for MDSAP Audit Areas | 1 min 10 secs |
Preparing for MDSAP Audit: Training/Briefing | 1 min 01 sec |
MDSAP and Management Review | 51 secs |
Preparing for Audit: Gap Analysis | 1 min 30 sec |
Documents to Prepare | 55 secs |
Internal Audit-MDSAP Requirement | 48 secs |
QMS Assessment Checklist: Benchmarking/Internal Audit | 1 min 15 sec |
Internal Audits Plan Checklist | 1 min 30 sec |
The Compliance Matrix: A Valuable Tool | 1 min 09 sec |
Quality System Changes: ISO 13485:2016 and 21 CFR 820 | 1 min 28 sec |
Preparing for the MDSAP: Conclusion | 1 min 22 sec |
Module 4: The MDSAP Audit
What’s Needed for Manufacturers Participation | 1 min 12 secs |
MDSAP Audit: General Information | 1 min 55 secs |
The “Model Audit” Document | 1 min 02 secs |
MDSAP Audit Scheduling | 1 min 25 secs |
Length of an MDSAP Audit | 1 min 45 secs |
Timing for Answers During Audit | 1 min 38 secs |
MDSAP Update on Audit Duration Adjustment | 1 min 49 secs |
Sterile Medical Device Manufacturers: MDSAP | 1 min 39 secs |
When are MDSAP Audits Conducted? | 1 min 30 secs |
The MDSAP Audits | 1 min 01 secs |
Stage 1: Initial Audit | 58 secs |
Stage 2: Evaluation of QMS Implementation and Effectiveness | 50 secs |
MDSAP : Surveillance Audit Timing | 1 min 09 secs |
Stage 3: Recertification Audit | 1 min 18 secs |
Audit Model: Special Audits and Short-Notice Audits | 1 min 29 secs |
Special Audits and “Recertification” Terms | 1 min 05 secs |
Audits Conducted by Regulatory Authorities | 1 min 39 secs |
Unannounced Audits | 1 min 19 secs |
Non-Conformities: MDSAP Grading | 1 min 30 secs |
Non-Conformities and Interrelationship | 1 min 40 secs |
The Audit and MDSAP Roles and Responsibilities | 50 secs |
Conclusion
Final Assessment
Certification
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