|Program/Course ID: ISOPCRT|
Enrollment Period: 6 months.
Allocated Learning Time: ~12 - 18 hours.
Additional Resources: Supplemental materials/activities.
Method of Training: Online / Self-paced eLearning.Accessibility: 24/7 access to all program materials.
Courses: 8 courses included (see below).
Digital Badge: Issued upon completion.
Catalog: 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 $1295.00
Document a dedication to your career and job performance by earning a professional certification from Biopharma Institute.Training Provided By: Biopharma Institute
The learning objectives of this program are to understand what ISO 13485 is, and what some of the key advantages to an ISO 13485 certification can provide. This program will also provide an in depth understanding of which policies, procedures and systems need to be put in place to be able to implement and maintain compliance with the 13485 standards. The program will explain documentation requirements, the quality manual, the medical device file, control of documents, control of records and good documentation practices. The program will discuss management commitment, customer focus, quality policy, planning, responsibility, authority and communication and management review. The program will discuss the provision of resources, human resources, infrastructure, work environment and contamination control. The program will cover Part A of Product Realization including, planning of product realization, customer related processes and design and development.
The program goes on to describe that the primary part of the purchasing requirements for ISO 13485 is to ensure that purchased product conforms to specified purchasing information, which can essentially be broken down into three subsections, supplier selection and control, material specifications from qualified suppliers and verification of purchase product.
As one of the measurements of the effectiveness of the quality management system the organization must have documented processes to gather and monitor information to show that the customer requirements have been met.
On occasion there will be product that is nonconforming to the required product specification. This may occur at any stage of product realization, from an incoming material to an in-process check, or finished product testing or inspection prior to entering the market, or in some cases, even after a product has entered the market. The organization must have a process to ensure that product which does not conform to the product requirements is identified and controlled to prevent its unintended use or delivery.
ISO 13485:2016 Professional Certification Program Includes These Courses:
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.