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Home » US Medical Device Quality Assurance (QA) Professional Certification Program

US Medical Device Quality Assurance (QA) Professional Certification Program

Certification TrainingProgram/Course ID: QADPRO
Enrollment Period: 12 months (1 year).
Average Learning Time: ~29 - 43 hours.
Additional Resources: Supplemental materials/activities.
Method of Training: Online / Self-paced eLearning.
Accessibility: 24/7 access to all program materials.
Courses: Program includes 19 individual courses (see below).
Digital Badge: Issued upon completion.
Post-nominal Letters: QAPro™.
Catalog: Quality Assurance (QA).
Demonstration: Five (5) free trial courses are available.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
  Price: $2295.00 USD  

Document your dedication to compliance, safety, and job performance by earning a professional certification from Biopharma Institute

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

Description:

US Medical Device Quality Assurance (QA) Professional Certification Program is designed to train those involved in overseeing quality, auditing processes, or supervising a broad range of responsibilities, with quality being the major focus, within a GMP compliant medical device manufacturing company.

This program includes an overview of Good Manufacturing Practice and the Quality Management System (QMS). The program also dives into ISO 13485:2016 requirements described in Chapter 4: The Quality Management System (QMS) and Chapter 8, Part B: Measurement Analysis and Improvement.

The program moves on to provide a comprehensive overview on the best practices regarding management of manufacturing and quality control testing for medical devices. There are 15 areas of Part 820 training, including: General Provisions, Quality System Requirements, Design Controls, Document Controls, Purchasing Controls, Identification and Traceability, Production and Process Controls, Acceptance Activities, Nonconforming Products, Corrective and Preventive Action, Labeling and Packaging Control, Handling, Storage, Distribution and Installation, Records, Servicing, and Statistical Techniques.

To achieve a strong understanding of FDA 21 CFR Part 820, and how it applies to the many areas of a medical device manufacturing company, our US Medical Device Quality Assurance (QA) Professional Certification Program is a terrific choice.

Students earning this certification will have a strong understanding of industry regulations and standards. They will understand what is required to perform within the federal regulations and what is necessary to maintain quality and compliance. Most importantly, students taking this program will have gained the knowledge and skills to successfully contribute within a GMP-compliant medical device manufacturing environment.


US Medical Device Quality Assurance (QA) Professional Certification Program includes these courses:



Individual Course w/Certificate of Completion:

GMP: Good Manufacturing Practices

Course ID: ELM-103
Duration: 60 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

GMP: Good Manufacturing Practices - QMS, Premises and Personnel

Course ID: ELM-202
Duration: 30 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

ISO 13485:2016 - Chapter 4: The Quality Management System (QMS)

Course ID: ELM-802
Duration: 60 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

ISO 13485:2016 - Measurement Analysis and Improvement (Chapter 8 - Part B)

Course ID: ELM-808
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart A - General Provisions

Course ID: ELM-301
Duration: 30 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart B - Quality System Requirements (QSR)

Course ID: ELM-302
Duration: 30 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart C - Design Controls

Course ID: ELM-303
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart D - Document Controls

Course ID: ELM-304
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart E - Purchasing Controls

Course ID: ELM-305
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart F - Identification and Traceability

Course ID: ELM-306
Duration: 60 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart G - Production and Process Controls

Course ID: ELM-307
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart H - Acceptance Activities

Course ID: ELM-308
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart I - Nonconforming Products

Course ID: ELM-309
Duration: 60 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart J - Corrective and Preventive Action

Course ID: ELM-310
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart K - Labeling and Packaging Control

Course ID: ELM-311
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart L - Handling, Storage, Distribution and Installation

Course ID: ELM-312
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart M - Records

Course ID: ELM-313
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart N - Servicing

Course ID: ELM-314
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart O - Statistical Techniques

Course ID: ELM-315
Duration: 45 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 additional information on our training programs, to request a quote/invoice, or suggest a course, complete the form below or call toll free in the US/Canada: (888) 4-BIO-LRN. Callers from outside the US can dial +1 (201) 301-8370.

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