GDocP: How to Write an Effective Equipment User Requirement Specification (URS)
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Price: $199.00 USD  |
Download Document your dedication to quality, compliance, safety, and job performance by earning a certification of training.Training Program: GDocP: How to Write an Effective Equipment User Requirement Specification (URS)Training Provided By: Biopharma Institute Website: https://www.biopharmainstitute.com Schedule: Self-paced. Immediate access to training materials upon enrollment. Description:  User requirements should be the starting point of any project you are working on. Time well-spent developing solid user requirements will help you enormously further down the line when you need to test your new equipment and associated software. A poorly written URS can result in miscommunication between the end-user and the equipment or system manufacturers which in turn can lead to wasted time, money and also project delays. In this course, we will learn how to write an effective Equipment URS.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'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 promptly launched and made available to the student upon course completion. Certificates are issued in an encrypted PDF format, and include a watermark, unique validation code, and QR verification barcode. Once all training requirements have been satisfied the achievement can be verified from our website using the unique certificate ID or QR barcode located on the certificate. For professional certification programs, a digital badge is additionally issued to verify training and document the achievement. Digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr. 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. |
Outline:Introduction Overview Learning Objectives Who Should Take This Course? Course Modules URS Basics What is a URS? Benefits of a URS Regulatory requirements URS preparation process Step 1: Identification of the URS team Step 2: Outlining the scope Step 3: Information gathering Step 4: Data analysis & draft URS document Step 5: URS reviewed by designated reviewers Step 6: URS reviewed by designated reviewers Equipment URS document structure Knowledge check How to Write User Requirements Key considerations Writing the specification and project cost Legal action A typical example Contract fundamentals The requirement specification template Requirement specification template - tips Citing regulatory standards Citing regulatory standards - example Citing regulatory standards - basic format Performance Vs design objectives Performance Vs design objectives - specification example HPLC/GC example Quantities A quantities example Verification of requirements Verification of requirements - examples Tolerances Tolerances - examples Acceptance criteria Acceptance criteria - examples Warranty Warranty continued Knowledge check How to Create a Bullet Proof URS The starting point Get SMART Clear & concise One requirement at a time Change control Testable Avoid duplication Prioritize requirements Design review & traceability Not fully defined Clear communication Business and process knowledge Ownership Typical equipment URS Requirement planning pitfalls Suppler / Vendor Management Audit your vendors and suppliers Compare your vendors and suppliers Functional or design specifications User documentation and training Requirement planning pitfalls Conclusion Final Assessment Certification | Objectives:Skill Level: Intermediate This training program has been developed to train employees with Intermediate Knowledge of Good Documentation Practices (GDocP). | |
This Course is Included in the Following Professional Certification Program(s):
 | Good Documentation Practices (GDocP) Professional Certification ProgramProgram ID: GDOCPPrice: $1695.00 (USD) |
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. |
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| 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. |
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