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Home » MDSAP: Medical Device Single Audit Program - Part 2 of 3

MDSAP: Medical Device Single Audit Program - Part 2 of 3

MDSAP: Medical Device Single Audit Program - Part 2 of 3 Certification Training

 
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Program/Course ID:ELM-136
Enrollment Period:12 months.
Average Learning Time:~45 minutes.
Additional Resources:Supplemental materials/activities.
Accredited Program:0.1 CPD Credits.
Method of Training:
Online, asynchronous, self-paced eLearning.
Accessibility:24/7 access to all program materials.
Demonstration:Four (4) free trial courses are available.
Group/Employee Training: Click here to request a quote.
Final Assessment:Multiple choice; unlimited attempts.
Certificate:Encrypted PDF with validation QR barcode.

2024 UPDATE:
This program is currently unavailable for enrollment.

It may have been updated or discontinued.
Check for newer version in our catalog.


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Outline:


Introduction
Overview
Learning objectives
Who should take this course?
Terms explained
Course modules

Preparing for MDSAP Audit Process
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

The MDSAP Audit
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

Objectives:


Skill Level:
Intermediate

This training program has been developed to train employees with Intermediate Knowledge of Medical Device Single Audit Program (MDSAP).

This Course is Included in the Following Professional Certification Program(s):



Training Program For Professionals:

Medical Device Single Audit Program (MDSAP) for Professionals

Course ID: MDSAP
Price: $1195.00 (USD)

Benefits of Being Certified from Biopharma Institute: Throughout our training students will be engaging in active learning using interactive eLearning modules validated by 3rd party organizations for relevancy, compliance, and regulatory content. Courses are developed by subject matter experts (SMEs) and instructional design professionals with the goal to promote the students' retaining of key knowledge. The programs further offer access to regulatory references, real-life case studies, and introduce other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with fulfilling training requirements. Biopharma Institute's certifications are recognized by a wide spectrum of industries, regulators, and companies around the world. Furthermore, our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 300 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity. We supply our training to clinical research, pharmaceutical, and medical device industries.

Employee / Corporate Training: For corporations seeking a method to train employees, economically, without having to set aside time for travel, webinars, or live, in-person training; Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, self-paced learning experience which fits conveniently into the day-to-day activities of most types of learners. Our eLearning modules are SCORM-compliant and can be delivered from most corporate learning management systems (LMS). We catering to both small-scale and large-scale training requests, with the same goal in mind: To make this a good experience for everyone involved, from the students to those managing the group training.


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Self-paced, asynchronous eLearning:24/7 access to all course materials and assessments for 12 months.
Open enrollment:No prior course prerequisites or work experience required.
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Flexible final assessments:Multiple-choice questions can be taken repeatedly until a passing score is achieved.
Direct access to certificates:Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode.
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