CEU Credits: 0.1
Course Code: ELM-136
Duration: 45 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Curriculum for this course
Overview
Learning objectives
Who should take this course?
Terms explained
Course modules
Audit Criteria Built Into IMDRF Audit Model
The MDSAP Audit and Preparation
Manufacturers Guide to prepare for MDSAP
Where to Begin Preparation
Preparing for MDSAP: Ensuring Consistency
Sterile Medical Device Requirements
QMS: Deciding Which Processes Will Be Audited
How to Prepare for MDSAP Audit Areas
Preparing for MDSAP Audit: Training/Briefing
MDSAP and Management Review
Preparing for Audit: Gap Analysis
Documents to Prepare
Internal Audit-MDSAP Requirement
QMS Assessment Checklist: Benchmarking/Internal Audit
Internal Audits Plan Checklist
The Compliance Matrix: A Valuable Tool
Quality System Changes: ISO 13485:2016 and 21 CFR 820
Preparing for the MDSAP: Conclusion
What’s Needed for Manufacturers Participation
MDSAP Audit: General Information
The “Model Audit” Document
MDSAP Audit Scheduling
Length of an MDSAP Audit
Timing for Answers During Audit
MDSAP Update on Audit Duration Adjustment
Sterile Medical Device Manufacturers: MDSAP
When are MDSAP Audits Conducted?
The MDSAP Audits
Stage 1: Initial Audit
Stage 2: Evaluation of QMS Implementation and Effectiveness
MDSAP : Surveillance Audit Timing
Stage 3: Recertification Audit
Audit Model: Special Audits and Short-Notice Audits
Special Audits and “Recertification” Terms
Audits Conducted by Regulatory Authorities
Unannounced Audits
Non-Conformities: MDSAP Grading
Non-Conformities and Interrelationship
The Audit and MDSAP Roles and Responsibilities
Conclusion
Final Assessment
Certification
