Student Login |


Sunday, December 04, 2022
Home » US Medical Device Quality Assurance (QA) Professional Certification Program

US Medical Device Quality Assurance (QA) Professional Certification Program

Certification Training
 
Rated 5 / 5
1 reviews
Program/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 courses).
Outline/Syllabus: See individual course pages for outlines.
Digital Badge: Issued upon completion.
Post-nominal Letters: QAPro™.
Catalog: Quality Assurance (QA).
Demonstration: Five (5) 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: $2295.00 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:

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 FDA 21 CFR 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, root cause analysis, corrective and preventive action (CAPA), labeling and packaging control, handling, storage, distribution and installation, records, servicing, and statistical techniques.

This program aims to deliver a strong understanding of FDA 21 CFR Part 820, and how it applies to the many areas of a medical device manufacturing company.

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 within the US medical device manufacturing company. Most importantly, students completing 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 19 individual courses:

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



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 Information:

Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessments 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 the accomplishment.

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 catering to both small and large-scale training requests.


Benefits of Training with Biopharma Institute

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Self-paced courses: 24/7 access to individual courses for 6 months and 1 year for professional certification programs.
  • Expertise: All courses have been developed by subject matter experts (SMEs) in the area of material being taught.
  • Current and validated: All courses are current with respect to regulations and procedures, and are 3rd party validated and/or accredited.
  • Optimized for learning: Courses include voiceovers, easy navigation, case studies, progress checks, and high-quality animations to increase retention of subject matter.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for malware to deliver optimal level of security and performance.
  • Training manager access: Our proprietary Training Manager Portal offers managers access to download their group enrollments, training records, account balance, and so much more.
  • Purchase orders (POs): If issuing 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.
  • Reimbursement: Some employers may reimburse for training expenses. Check 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.
  • Flexible final assessments: Assessments include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to your career and job performance. They may be helpful for those seeking a new career or transitioning to different positions within their organization.
  • Direct access to certificates: Certificate of completion is instantly available once requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all professional certification programs.


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.

Name:
Company:
Phone:
Email:
 
Enter the number from the image above:
Comments:


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