Student Login |

Thursday, September 23, 2021
Home » Medical Device Single Audit Program (MDSAP) - Part 2

Medical Device Single Audit Program (MDSAP) - Part 2

Certification TrainingProgram/Course ID: ELM-136
Enrollment Period: 3 months.
Allocated 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.
CPD Accredited TrainingCatalog: 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 $199.00

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

Training Program: Medical Device Single Audit Program (MDSAP) - Part 2
Training Provided By: Biopharma Institute

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute ReviewsAccording to the Audit Model, the manufacturer must be able to map all processes, their links, and the ISO 13485 clause relating to them, and compare to the company processes and Standard Operating Procedures (SOPs), Quality Manual etc. This course will discuss this Audit Model further and the Best Industry Practices for organizing, training, and remediation of company processes and the quality management system.

Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment within a 90-day/3-month period (180 day/6-month period for Professional Certification Programs). Certificate of completion is accessible in PDF format immediately after satisfying 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. Course takers can attempt the final assessment any number of times, as needed, to achieve a passing score. Once all training requirements have been satisfied a certification of training has been achieved and can be verified immediately from our website using a unique certification ID code. The 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 verify training, and can be displayed on social networking sites, such as LinkedIn.


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


Final Assessment



Skill Level:

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

Medical Device Single Audit Program (MDSAP) - Part 2 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) | 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 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.

Information Request / Suggest a Course Form:

Enter the number from the image above
COMMENTS or Suggest a course:
(For pricing information, please provide us with as much detail as possible about your training project):