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

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

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

 
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Program/Course ID:ELM-137
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

MDSAP Roles and Responsibilities During the Audit
Audit Tasks: Audit Model Used by Auditor
When Are Suppliers Involved in MDSAP?
Audit Organizations (AOs) and the Audit
Auditing Organization: Evaluation and Review
Auditing Organization Assessments: Regulatory Assessment
Regulatory Authority Assessor: Enforcement
Appeals to the Regulatory Authorities
Auditing Authority Complaints
Auditing Organizations: Accreditation
Who can become an MDSAP Auditor?
Cost and Training for MDSAP Audit Training
Roles: Regulatory
Roles: Consultancy Organizations
Collaboration with MDSAP Experts

Benefits and Future of MDSAP
MDSAP Success Based on Multiple Factors
Overall Benefits of MDSAP Implementation
Manufacturer Benefits of MDSAP Implementation
Advantages for MDSAP Participants
Benefits for Each Country Participant
Future of MDSAP
MDSAP Drawbacks
Challenges of MDSAP Participation
Combating Industry Fears
MDSAP Transition Plan Changes

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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Benefits of Training with Biopharma Institute

Immediate access to courses:Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment.
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.
Expertise:Courses developed by subject matter experts (SMEs) in the area being taught.
Current and validated:Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited.
Optimized for learning:Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter.
Secure and safe access:Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance.
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.
Verification of training:Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally issued for all professional certification programs.
Training manager access:A proprietary portal offers access to download enrollment reports, training records, account balance, and more.
SCORM-compliant courses:Courses can be delivered directly to most corporate Learning Management Systems (LMS).
Purchase orders (POs):POs are accepted from all companies. Request an invoice when starting the procurement process.
Reimbursement:Some employers may reimburse their employees for training expenses. Check your company's policy.
Financial assistance:Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option.
Career advancement:Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties.

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