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Home » Medical Device Single Audit Program (MDSAP) for Professionals

Medical Device Single Audit Program (MDSAP) for Professionals

Medical Device Single Audit Program (MDSAP) for Professionals Certification Training
 
Rated 4.1 / 5
15 reviews
Program/Course ID: MDSAP
Enrollment Period: 12 months.
Average Learning Time: ~15 - 23 hours.
Additional Resources: Supplemental materials/activities.
Method of Training: Online, asynchronous, self-paced eLearning.
Accessibility: 24/7 access to all program materials.
Courses: Program includes 10 individual courses (see courses).
Outline/Syllabus: See individual course pages for outlines.
Digital Badge: Issued upon completion.
Catalog: Medical Device Regulatory Affairs.
Demonstration: Three (3) free trial courses are available.
Group/Employee Training: Click here to request a quote.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
  Price: $1195.00 USD  

Document your dedication to compliance, safety, and job performance by earning a professional certification.

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

Outline/Syllabus: See individual course pages for outline.
Description:

Medical Device Single Audit Program (MDSAP) for Professionals 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 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. This must be compared to the company processes and Standard Operating Procedures (SOPs), Quality Manual, and 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.

Upon completion of this program, students 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 move on to focus on providing a detailed information on 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 10 individual courses:

(Click on course links below to see outline/syllabus)



Individual Course w/Certificate of Completion:

MDSAP: Medical Device Single Audit Program - Part 1 of 3

Course ID: ELM-135
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

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

Course ID: ELM-136
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

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

Course ID: ELM-137
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

MDSAP: Medical Device Single Audit Program - 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:

MDSAP: Medical Device Single Audit Program - 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:

MDSAP: Country Specific Requirements for USA

Course ID: ELM-143
Duration: 60 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

MDSAP: Country Specific Requirements for Canada

Course ID: ELM-142
Duration: 60 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

MDSAP: Country Specific Requirements for Australia

Course ID: ELM-140
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

MDSAP: Country Specific Requirements for Brazil

Course ID: ELM-141
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

MDSAP: Country Specific Requirements for Japan

Course ID: ELM-144
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Additional Information:

Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment for each course within a 12-month period. Certificate of completion is accessible in PDF format immediately after satisfying the requirements.

Biopharma Institute certificates and digital badges include the date of completion, but do not have an expiration date. However, compliance training is typically considered valid for a period of 3 years. Many organizations suggest that compliance training should be refreshed at least every three years to stay up to date with regulations, standards, guidelines, and to reinforce the importance of maintaining compliance. The validity or recertification period for employee compliance training would be determined by those responsible for managing quality within the company.

Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student following enrollment into any program or course. Students may 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 ID code located on the certificate. The professional certificate of completion is also instantaneously launched and made available to the student in a PDF format.

Additionally, once the student has completed the professional certification program, a digital badge is issued. The digital badge documents all the courses taken and completed within the program, to further validate the student's achievement. Digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Badgr, and others, to display accomplishments.

Benefits of Being Certified from Biopharma Institute: Throughout the online training courses students will be engaging in active learning using interactive eLearning modules developed to promote the retaining of key knowledge. Furthermore, students will be provided with access to references, the regulatory guidelines, case studies, and other important information necessary to gain a professional understanding for the discipline.

Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with attaining their training requirements. Our courses are developed by subject matter experts (SMEs) in the topic of study and have all been validated and/or accredited by a neutral 3rd party. Biopharma Institute certifications are recognized by regulators and companies in a wide range of industries around the world.

Biopharma Institute has training solutions which are customizable to any organization's training needs. We aim to provide only the highest quality of training, which is current, engaging, effective, and easy to navigate.

Today, Biopharma Institute has over 200+ courses in its catalog. These courses train on clinical trials, drug manufacturing, regulatory affairs, validation systems, drug safety, pharmacovigilance, good laboratory practice, and data integrity; all within the medical device, clinical research, and pharmaceutical 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 cater to both small and large-scale training requests.


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:Certificate of completion is instantly available once requirements have been fulfilled.
Verification of training:Certificates verifiable online with digital badges 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.



Have Questions? Contact Us:

Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.

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For quotes or invoices please provide the course(s) and number of students.