Enrollment Period: 6 months.
Average Learning Time: ~45 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 0.1 CPD Credits.
Method of Training: Online / Self-paced eLearning.Accessibility: 24/7 access to all program materials.
Catalog: Medical Device Regulatory Affairs.
Demonstration: Five (5) free trial courses are available.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
Price: $199.00 USD
Document your dedication to quality, compliance, safety, and job performance by earning a training certification.Training Program: MDSAP: Medical Device Single Audit Program - Part 1 of 3
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon enrollment.
This course will examine the process of preparing and applying for the Medical Device Single Audit Program (MDSAP). It is written from the perspective of the Medical Device company that is considering joining or in the process of joining the program. In addition, an overview of the MDSAP program will be provided, as well as links to more in-depth information on certain topics.
Certification Requirements: Students must view the entire course and successfully pass an online, multiple-choice final assessment within a 6-month period, or a 12-month period for professional certification programs. A certificate of completion is immediately accessible in PDF format after satisfying the requirements.
Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment any number of times, as needed, to achieve a passing score. The certificate of completion is instantaneously launched and made available to the student in a PDF format upon completion.
Once all training requirements have been satisfied the achievement can be verified from our website using the unique ID code found on the certificate. Professional certification programs issue a digital badge to verify training and document the achievement. These digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr.
Who should take this course?
Introduction to MDSAP
What is MDSAP?
International regulators: IMDRF
Parties involved in MDSAP and MDSAP pilot creation
International medical device regulators forum (IMDRF)
History of IMDRF
IMDRF and MDSAP requirements/documentation
The purpose of the MDSAP pilot
The MDSAP pilot timeline
The MDSAP timeline
MDSAP pilot program participating countries
International regulatory authorities participation
Observers of the MDSAP pilot and program
MDSAP - Roles of participants and observers
Pilot MDSAP 'Criteria for Success'?
How the MDSAP pilot audit was conducted
MDSAP pilot grading system
MDSAP Pilot: Mid-pilot status report
MDSAP Pilot: List of auditing organization participants
Expected improvements from implementing MDSAP pilot program audit model
Benefits of the 'All-in-One'? audit model
Manufacturers' benefits of participating in MDSAP pilot
MDSAP pilot goals and future MDSAP use
MDSAP pilot audit model online
FDA site specific online information/forms
MDSAP online policies, procedures, templates and forms
MDSAP FDA and ANSA question and answer site
MDSAP document for audit assessment
The MDSAP Audit Model Overview
About MDSAP objectives
The MDSAP equals one audit for five countries
International participation and exclusions
MDSAP International and US participation
Manufacturers exceptions for inclusion in MDSAP: Electronic product radiation control
MDSAP audit plan has mapped requirements
MDSAP audit model structure
MDSAP Effectiveness: External factors
MDSAP impact on ISO 13485:2016
ISO 13485 versions
ISO 13485:2016 alignment with MDSAP
MDSAP audit general focus
The MDSAP audit-process approach
MDSAP Audit Roadmap: Seven process chapters
MDSAP sequence and interrelationships
Process Linkages (Interrelationships): audit model
MDSAP Audit Structure: Seven processes
Audit Model-FDA document P002 and companion document online
This training program has been developed to train employees with Basic Knowledge of Medical Device Single Audit Program (MDSAP).
MDSAP: Medical Device Single Audit Program - Part 1 of 3 is included in the following professional certification programs:
Price: $1195.00 (USD) | Learn more
Benefits of Being Certified from Biopharma Institute: Throughout many of our online training programs students will be engaging in active learning through the use of interactive eLearning modules validated by 3rd party organizations for relavancy and regulatory content. The courses are developed by subject matter experts (SMEs) to promote the retaining of key knowledge. They 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 200 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity for the clinical research, pharmaceutical, and medical device industries.
Group Training for Employees: 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.
Benefits of Training with Biopharma Institute
- Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
- Self-paced courses: 24/7 access to individual courses for 6 months and 1 year for professional certification programs.
- Optimized for learning: Courses include voice-overs, easy navigation, case studies, progress checks, and high-quality animations to increase retention of subject matter.
- Verification of training: Certificates can be verified online, and digital badges are issued for all professional certification programs.
- Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for malware to deliver optimal level of security and performance.
- Purchase orders (POs): If a PO is required by your company, request an invoice to start the procurement process. we accept all purchase orders.
- Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
- Tuition reimbursement: Some employers may reimburse for training expenses. Check your company's training reimbursement policy.
- Career advancement: Professional certifications help demonstrate your interest and dedication to your career and job performance. They may be helpful for those seeking a new career or transitioning to different positions within their organization.
- Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
- Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
- Direct access to certificates: Certificate of completion is instantly available once requirements have been fulfilled.