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Thursday, September 23, 2021
Home » Medical Device Single Audit Program (MDSAP) for Professionals

Medical Device Single Audit Program (MDSAP) for Professionals

Certification TrainingProgram/Course ID: MDSAP
Enrollment Period: 6 months.
Allocated Learning Time: ~11 - 16 hours.
Additional Resources: Supplemental materials/activities.
Method of Training: Online / Self-paced eLearning.
Accessibility: 24/7 access to all program materials.
Courses: 7 courses included (see below).
Digital Badge: Issued upon completion.
Catalog: Medical Device Regulatory Affairs.
Demonstration: See free trial enrollment courses.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).

PRICE: USD $1195.00

Document a dedication to your career and job performance by earning a professional certification from Biopharma Institute.

Biopharma Institute ReviewsTraining Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Description:

This program 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.

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 compared to the company processes and Standard Operating Procedures (SOPs), Quality Manual etc. This program will discuss this Audit Model further and the Best Industry Practices for organizing, training, and remediation of company processes and the quality management system.

This program 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.

Upon completion of this program, you will have a comprehensive understanding of the general MDSAP requirements that affect all five MDSAP countries, including the following content from the Audit Model, MDSAP Basics, MDSAP Audit Model, Chapter 1: Process: Management, Chapter 2: Process: Audit Tasks and Links, Chapter 3: Process: Measurement, Analysis and Improvement and Chapter 4: Process: Medical Device Adverse Events and Advisory Notices Reporting.

Health Canada is the agency of the Canadian government that is responsible for national health policy and compliance, among other obligations. The agency has been a participating member of the MDSAP consortium working group, the International Medical Device Regulators Forum (IMDRF), in developing the MDSAP program. Canada's transition to MDSAP was initially announced in 2015, confirming the requirement for medical device manufacturers to transition from the Canadian Medical Devices Conformity Assessment System (CMDCAS) to MDSAP to continue to place devices within Canada.

The program continues to provide a high-level overview of each of the process chapters of the Medical Device Single Audit Program (MDSAP). Consequently, the country-specific MDSAP requirements are reviewed separately from these general MDSAP courses. In this program, we will focus on providing a detailed discussion of the United States Food and Drug Administration's (FDA) country-specific requirements for the process chapters of MDSAP.


Medical Device Single Audit Program (MDSAP) for Professionals Includes These Courses:



 Individual Course w/Certificate of Completion: 
Medical Device Single Audit Program (MDSAP) - Part 1
Course ID: ELM-135
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

 Individual Course w/Certificate of Completion: 
Medical Device Single Audit Program (MDSAP) - Part 2
Course ID: ELM-136
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

 Individual Course w/Certificate of Completion: 
Medical Device Single Audit Program (MDSAP) - Part 3
Course ID: ELM-137
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

 Individual Course w/Certificate of Completion: 
Medical Device Single Audit Program (MDSAP) - Chapters 1 to 4
Course ID: ELM-138
Duration: 60 minutes (0.1 CPD Credits)
Price: Included | Learn more

 Individual Course w/Certificate of Completion: 
Medical Device Single Audit Program (MDSAP) - Chapters 5 to 7
Course ID: ELM-139
Duration: 60 minutes (0.1 CPD Credits)
Price: Included | Learn more

 Individual Course w/Certificate of Completion: 
Medical Dev: MDSAP Country Specific Requirements (Canada)
Course ID: ELM-142
Duration: 60 minutes (0.1 CPD Credits)
Price: Included | Learn more

 Individual Course w/Certificate of Completion: 
Medical Dev: MDSAP Country Specific Requirements (USA)
Course ID: ELM-143
Duration: 60 minutes (0.1 CPD Credits)
Price: Included | Learn more

Additional Details:

Certification Requirements: Students must view the entire program and successfully pass online, multiple-choice final assessments for each course within a 180 day/6-month period. Certificate of completion is accessible in PDF format immediately after satisfying the requirements.

Biopharma Institute's online training programs include immediate access after enrollment. Username, password, and instructions are emailed to the student following enrollment into the program. Program enrollees can attempt the final assessments any number of times, as needed, to achieve a passing score. Once all training requirements have been satisfied a professional certification has been achieved and can be verified immediately from our website using a unique certification ID code. The professional certificate of completion is also instantaneously launched and made available to the student in a PDF format upon completion. Professional certification programs additionally include a digital badge to validate the training achieved. Digital badges can be displayed on social networking sites, such as LinkedIn.

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 which have been developed to promote the retaining of key knowledge, access to references, case studies, and other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and corporations with their training requirements. Biopharma Institute certifications are recognized by a wide spectrum of industries and companies, and our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing, regulatory affairs, validation systems, pharmacovigilance, good clinical laboratory practice (GCLP), data integrity, and medical devices.

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 (1-100 students) and large-scale (100+ students) training requests.


Online Training: The Benefits of Remote Learning & eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter.
  • Self-paced courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days.
  • 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 course requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's training reimbursement policy.
  • 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.
  • Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process.
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.


Contact Us:

For more information on the Biopharma Institute's training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370.

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