Duration: 4 hours, Online (the average time to complete the training program, including final assessments).Credit Hours: See individual courses for credit hours assigned.
Self-paced Training: 24/7 access to course.
Enrollment Period: 6 months.
Catalog: Medical Device Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.
PRICE: USD $395.00
This Global Medical Device Regulatory Affairs Professional Certification Program is an online program which guides the student through a global medical device regulations overview. It discusses how ISO13485:2003 (the ISO standard) relates to the industry of medical devices, details the regulatory expectations for quality management system (QMS) certification, and identifies vital elements of the essential and standard administration rules. It presents and discusses the key differences between ISO13485 and ISO9000, and as they apply to QMS medical devices. The course identifies the risk management process, explains the terminology, details the required documentation, and discusses how risk can be calculated.
The following three areas of training are included in the program: Global Risk Management; Requirements of Global Quality Management Systems; and Global Medical Device Regulatory Affairs. Once course requirements have been satisfied a Certificate of Completion will be made available.
Benefits of Getting Certified at BioPharma Institute
BioPharma Institute has been in existence for over two decades has become one of the top online training institutes for professionals who work in the pharmaceutical, biotechnology, and healthcare industries. Thousands of businesses have been aided by our high-quality instruction, courses, and techniques. Major players in the industry are just a sampling of the companies with whom we have worked. Our certifications are recognized in a large spectrum of industries and our training solutions can be customized to meet the needs of most organizations.
BioPharma Institute has a state-of-the-art e-learning system which makes online learning easy. We provide various educational implements to help students learn the essential aspects of the industry. No matter if your organization is a large-scale operation or a small-scale business, whether you need to train new employees or take a refresher course, our exceptional industry knowledge and infinite resources deliver supreme training for you, your employees, and your colleagues.
Training Provided By: BioPharma Institute
The Global Medical Device Regulatory Affairs Professional Certification Program includes these individual courses:
Online Training Program Benefits:
- Immediate access to training: Instructions, username, password and receipt of payment 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 180 days for professional certification programs
- Flexible final assessments: Tests include multiple-choice questions and can be taken repeatedly until a passing score is achieved
- Direct access to certificates: Documentation instantly available once course requirements have been fulfilled
- Verification of training: Certificates can be verified online, and electronic badges are issued for all Professional Certification programs
- Corporate reimbursements: Employers may pay for or reimburse employees for training. Purchase orders (POs) for both individual and group training are accepted
- Corporate LMS solutions: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
- Secure and safe access: Website and LMS offer an encrypted connection with firewall protection and daily scans for optimal level of security and performance
- Career advancement: Professional certifications may be helpful for those seeking new careers or transitioning to different positions within their organization
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, or email Support@BioPharmaInstitute.com.