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Medical Dev: MDSAP Country Specific Requirements (USA)

Certification TrainingProgram/Course ID: ELM-143
Enrollment Period: 3 months.
Allocated Learning Time: ~60 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 Dev: MDSAP Country Specific Requirements (USA)
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

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

Description: Online training with immediate access upon enrollment. Biopharma Institute ReviewsIn previous courses, we focused on providing 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 course, we will focus on providing a detailed discussion of the United States Food and Drug Administration's country-specific requirements for the process chapters of MDSAP, as they were not covered in detail in the general MDSAP courses.

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.


Outline:


Introduction
Overview
Learning Objectives
Who Should Take This Program?
Glossary

MDSAP Basics
MDSAP Audit Model
MDSAP and the USA
Benefits of MDSAP to the USA
USA Regulatory Authorities and MDSAP Exclusions

Chapter 1 - Process: Management
Auditing the Management Process
Audit Task 8

Chapter 2 - Process: Device Marketing Authorization and Facility Registration
Auditing the Device Marketing Authorization and Facility Registration Process
Audit Task 1
Audit Task 2
Audit Task 3

Chapter 3 - Process: Measurement, Analysis and Improvement
Auditing the Measurement, Analysis and Improvement Process
Audit Task 1
Audit Task 12
Audit Task 12: US FDA-Specific Requirements

Chapter 4 - Process: Medical Device Adverse Events and Advisory Notices Reporting
Auditing the Medical Device Adverse Events and Advisory Notices Reporting Process
Audit Task 1
Audit Task 2

Chapter 5 - Process: Design and Development
Auditing the Design and Development Process
Audit Task 4
Audit Task 5
Audit Task 8
Audit Task 13
Audit Tasks 14

Chapter 6 - Process: Production and Service Controls
Auditing the Production and Service Controls Process
Audit Task 1
Audit Task 7
Audit Task 16
Audit Task 17
Audit Task 18
Audit Task 21
Audit Task 25
Audit Task 27

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).

Medical Dev: MDSAP Country Specific Requirements (USA) 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:

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