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    • Live Courses/Webinars
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    • By Category
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      • DIGR-ACT: Critical Thinking Skills for Clinical Trials
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HomeManufacturing (GMP)User Requirements Specifications: A Compliance Primer

User Requirements Specifications: A Compliance Primer

Teachers
Christina Meyer Dell Cioppia
Category:
Introductory Pharma Courses/ Manufacturing (GMP)/ On-Demand Courses/ Regulatory & Compliance/ Research & Development/
Clear
Duration: 90 minutes
On-demand
Includes handouts
  • Description
  • Who Should Attend
  • What To Expect

Description

COURSE DESCRIPTION

OVERVIEW

User Requirement Specifications (URS) are the foundation of capital projects, remediation projects, and process modifications from tech transfer, through design, qualification, and validation.  The importance of robust, meaningful and quantifiable User Requirements cannot be understated.  Regardless of the application, direct input from the process or product end user is critical to its design, as is the transfer of that input to the final URS document.  Despite this, URS documents are often largely overlooked, and addressed late in the project lifecycle only to satisfy a project stage-gate or quality requirement.

LEARNING OBJECTIVES

Join our interactive online training course where you will to learn:

  1. Regulatory and compliance basis for URS
  2. Development of an overarching User Requirement Brief (URB)
  3. Development of meaningful and measurable User Requirement Specifications
  4. Common pitfalls in URS development
  5. Utilizing URS to “validate” system design and deliverables
  6. Utilizing URS as a planning tool for commissioning, qualification, and validation

Who Should Attend

WHO SHOULD ATTEND

This course will be of benefit to anyone involved in capital projects within the life sciences/pharmaceutical industries and particularly those involved in conceptual and preliminary design, commissioning, qualification, and validation.  Additionally, this course will benefit those involved in qualification and validation remediation activities and periodic reviews.

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 (9am – 5pm EST, M-F) for assistance.

About Instructors

Christina Meyer Dell Cioppia
Has assisted biopharma, vaccine, pharma, and aseptic processing firms worldwide in commissioning, qualification, validation, design reviews, cGMP audits, and worldwide regulatory compliance.

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Clear
Duration: 90 minutes
On-demand
Includes handouts

CATEGORIES

  • Coronavirus / COVID-19 (4)
  • Clinical Trials (GCP Training) (110)
  • Introductory Pharma Courses (18)
  • IT & Data Integrity for Pharma (33)
  • Leadership & Training (40)
  • Live Webinars (7)
  • Manufacturing (GMP) (92)
  • Medical Device Training (63)
  • On-Demand Courses (233)
  • Quality (52)
  • Regulatory & Compliance (208)
  • Research & Development (80)
  • Special Packages (5)

Upcoming Live Courses

  • China GCP 2020: Understanding and Implementing New Compliance Requirements
  • How to Prepare for FDA Guidance on Computer Software Assurance (CSA) in 2021 – A Two Part Primer
  • It is Finally Here! Update to the ISO Medical Device GCP Standard: ISO 14155:2020
  • Preparing for Changes to ICH GCP E6(R3) and ICH E8(R1) – Readying for Risk Mitigation

TOPICS

Cleaning Validation Cleanroom Clinical Trials Cloud CMOs Computer Systems CRAs CROs Data Integrity Device eCTD EMA Equipment Facilities FDA GCP GDP GLP GMP HIPAA Human Error ICH Informed Consent Inspections Instructional Design Management manufacturing Marketing MDR microbial control Process Validation Project Management QMS Quality Quality by Design Quality Risk Management Remote Monitoring Risk Risk-Based Monitoring Root Cause Analysis Site Monitoring SOPs Training Trial Master File Upcoming Courses

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About Us

The Life Science Training Institute helps pharma, biotech, and medical device companies build knowledgeable, compliant workforces by providing training from drug discovery through commercialization. We are dedicated to advancing careers of those working to develop new therapies and to protect patient safety.

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  • 101 Gibraltar Road, Suite 100 Horsham, PA 19044
  • 215-675-1800 (option 3)
  • info@lifesciencetraininginstitute.com

Course Categories

  • Clinical Trials (GCP Training)
  • Coronavirus / COVID-19
  • Introductory Pharma Courses
  • IT & Data Integrity for Pharma
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  • Live Webinars
  • Manufacturing (GMP)
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