MDSAP: Medical Device Single Audit Program - Part 2 of 3
 | Enrollment Period: 12 months. Average Learning Time: ~45 minutes. Additional Resources: Supplemental materials/activities. Accredited Program: 0.1 CPD Credits. Method of Training: Online, asynchronous, self-paced eLearning. Accessibility: 24/7 access to all program materials. Catalog: Medical Device Regulatory Affairs.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: $199.00 USD |
Download Program DetailsDocument your dedication to quality, compliance, safety, and job performance by earning a training certification.Training Program: MDSAP: Medical Device Single Audit Program - Part 2 of 3Training Provided By: Biopharma Institute Website: https://www.biopharmainstitute.com Schedule: Self-paced. Immediate access to training materials upon enrollment. Description:  According to the Audit Model, the manufacturer must be able to map all processes, their links, and the ISO 13485 clause relating to them, and compare to the company processes and Standard Operating Procedures (SOPs), Quality Manual etc. This course will discuss this Audit Model further and the Best Industry Practices for organizing, training, and remediation of company processes and the quality management system.Certification Requirements: Students must view the entire course and successfully pass an online, multiple-choice final assessment within a 12-month period. A certificate of completion is immediately accessible in PDF format 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 period for employee compliance training would be determined by those responsible for managing quality assurance. 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. The certificate of completion is instantaneously launched and made available to the student in a PDF format upon completion. Once all training requirements have been satisfied the achievement can be verified from our website using the unique ID code found on the certificate. Professional certification programs issue a digital badge to verify training and document the achievement. These digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr. |
Outline:Introduction Overview Learning objectives Who should take this course? Terms explained Course modules Preparing for MDSAP Audit Process Audit Criteria Built Into IMDRF Audit Model The MDSAP Audit and Preparation Manufacturers Guide to prepare for MDSAP Where to Begin Preparation Preparing for MDSAP: Ensuring Consistency Sterile Medical Device Requirements QMS: Deciding Which Processes Will Be Audited How to Prepare for MDSAP Audit Areas Preparing for MDSAP Audit: Training/Briefing MDSAP and Management Review Preparing for Audit: Gap Analysis Documents to Prepare Internal Audit-MDSAP Requirement QMS Assessment Checklist: Benchmarking/Internal Audit Internal Audits Plan Checklist The Compliance Matrix: A Valuable Tool Quality System Changes: ISO 13485:2016 and 21 CFR 820 Preparing for the MDSAP: Conclusion The MDSAP Audit What's Needed for Manufacturers Participation MDSAP Audit: General Information The 'Model Audit'? Document MDSAP Audit Scheduling Length of an MDSAP Audit Timing for Answers During Audit MDSAP Update on Audit Duration Adjustment Sterile Medical Device Manufacturers: MDSAP When are MDSAP Audits Conducted? The MDSAP Audits Stage 1: Initial Audit Stage 2: Evaluation of QMS Implementation and Effectiveness MDSAP : Surveillance Audit Timing Stage 3: Recertification Audit Audit Model: Special Audits and Short-Notice Audits Special Audits and 'Recertification'? Terms Audits Conducted by Regulatory Authorities Unannounced Audits Non-Conformities: MDSAP Grading Non-Conformities and Interrelationship The Audit and MDSAP Roles and Responsibilities Conclusion Final Assessment Certification | Objectives:Skill Level: Intermediate This training program has been developed to train employees with Intermediate Knowledge of Medical Device Single Audit Program (MDSAP). | |
MDSAP: Medical Device Single Audit Program - Part 2 of 3 is included in the following professional certification programs:
 | Medical Device Single Audit Program (MDSAP) for ProfessionalsCourse ID: MDSAPPrice: $1195.00.00 (USD) | Learn more |
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 validated by 3rd party organizations for relevancy and regulatory content. The courses are developed by subject matter experts (SMEs) to promote the retaining of key knowledge. They 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 200 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity for the clinical research, pharmaceutical, and medical device industries.
Group Training for Employees: 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.
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: | Certificate of completion is instantly available once requirements have been fulfilled. |
| Verification of training: | Certificates verifiable online with digital badges 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. |
