US Medical Device Quality Assurance (QA) Management Professional Certification Program
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Price: $1995.00 USD |
Download Document your dedication to compliance, safety, and job performance by earning a professional certification. Training Provided By: Biopharma InstituteWebsite: https://www.biopharmainstitute.com Outline/Syllabus: See individual course pages for outline. Description: US Medical Device Quality Assurance (QA) Management Professional Certification Program is designed to train those involved in overseeing quality to assure US manufacturing regulations are being followed. It is appropriate for workers auditing processes or supervising a broad range of responsibilities, with quality being the major focus, within a GMP compliant medical device manufacturing company selling products into the USA. 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.
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 | GMP: Cases from History and the RegulationsCourse ID: ELM-201Duration: 30 minutes (0.1 CPD Credits) Price: Included |
 | GMP: Good Manufacturing Practices - QMS, Premises and PersonnelCourse ID: ELM-202Duration: 30 minutes (0.1 CPD Credits) Price: Included |
 | GMP: Equipment, Validation, Complaints and Self InspectionCourse ID: ELM-203Duration: 30 minutes (0.1 CPD Credits) Price: Included |
 | GMP: Good Manufacturing Practices - Good Practices and Quality ControlCourse ID: ELM-204Duration: 30 minutes (0.1 CPD Credits) Price: Included |
 | ISO 13485:2016 - Chapter 4: The Quality Management System (QMS)Course ID: ELM-802Duration: 60 minutes (0.1 CPD Credits) Price: Included |
 | ISO 13485:2016 - Measurement Analysis and Improvement (Chapter 8 - Part B)Course ID: ELM-808Duration: 45 minutes (0.1 CPD Credits) Price: Included |
 | GMP: 21 CFR Part 820 Subpart A - General ProvisionsCourse ID: ELM-301Duration: 30 minutes (0.1 CPD Credits) Price: Included |
 | GMP: 21 CFR Part 820 Subpart B - Quality System Requirements (QSR)Course ID: ELM-302Duration: 30 minutes (0.1 CPD Credits) Price: Included |
 | GMP: 21 CFR Part 820 Subpart C - Design ControlsCourse ID: ELM-303Duration: 45 minutes (0.1 CPD Credits) Price: Included |
 | GMP: 21 CFR Part 820 Subpart D - Document ControlsCourse ID: ELM-304Duration: 45 minutes (0.1 CPD Credits) Price: Included |
 | GMP: 21 CFR Part 820 Subpart E - Purchasing ControlsCourse ID: ELM-305Duration: 45 minutes (0.1 CPD Credits) Price: Included |
 | GMP: 21 CFR Part 820 Subpart F - Identification and TraceabilityCourse ID: ELM-306Duration: 60 minutes (0.1 CPD Credits) Price: Included |
 | GMP: 21 CFR Part 820 Subpart G - Production and Process ControlsCourse ID: ELM-307Duration: 45 minutes (0.1 CPD Credits) Price: Included |
 | GMP: 21 CFR Part 820 Subpart H - Acceptance ActivitiesCourse ID: ELM-308Duration: 45 minutes (0.1 CPD Credits) Price: Included |
 | GMP: 21 CFR Part 820 Subpart I - Nonconforming ProductsCourse ID: ELM-309Duration: 60 minutes (0.1 CPD Credits) Price: Included |
 | GMP: 21 CFR Part 820 Subpart J - Corrective and Preventive ActionCourse ID: ELM-310Duration: 45 minutes (0.1 CPD Credits) Price: Included |
 | GMP: 21 CFR Part 820 Subpart K - Labeling and Packaging ControlCourse ID: ELM-311Duration: 45 minutes (0.1 CPD Credits) Price: Included |
 | GMP: 21 CFR Part 820 Subpart L - Handling, Storage, Distribution and InstallationCourse ID: ELM-312Duration: 45 minutes (0.1 CPD Credits) Price: Included |
 | GMP: 21 CFR Part 820 Subpart M - RecordsCourse ID: ELM-313Duration: 45 minutes (0.1 CPD Credits) Price: Included |
 | GMP: 21 CFR Part 820 Subpart N - ServicingCourse ID: ELM-314Duration: 45 minutes (0.1 CPD Credits) Price: Included |
 | GMP: 21 CFR Part 820 Subpart O - Statistical TechniquesCourse ID: ELM-315Duration: 45 minutes (0.1 CPD Credits) Price: Included |
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's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment 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. Certificates are issued in an encrypted PDF format, and include a watermark, unique validation code, and QR verification barcode. Furthermore, a digital badge is also 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.
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.
Benefits of Being Certified from Biopharma Institute: Throughout our training students will be engaging in active learning using interactive eLearning modules validated by 3rd party organizations for relevancy, compliance, and regulatory content. Courses are developed by subject matter experts (SMEs) and instructional design professionals with the goal to promote the students' retaining of key knowledge. The programs further offer access to regulatory references, real-life case studies, and introduce other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with fulfilling training requirements. Biopharma Institute's certifications are recognized by a wide spectrum of industries, regulators, and companies around the world. Furthermore, our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 300 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity. We supply our training to clinical research, pharmaceutical, and medical device 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-scale and large-scale training requests, with the same goal in mind: To make this a good experience for everyone involved, from the students to those managing the group training.
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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: | Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode. |
| Verification of training: | Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally 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.
