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    • Live Courses/Webinars
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    • By Category
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      • Manufacturing
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      • Regulatory
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HomeOn-Demand CoursesAuditing Validated Computer Systems In A GxP Environment

Auditing Validated Computer Systems In A GxP Environment

Teachers
Alecia Adams
Category:
Clinical Trials & Good Clinical Practices (GCP) Training/ IT & Data Integrity for Pharma/ Manufacturing & Good Manufacturing Practices (GMP) Training/ On-Demand Courses/ Regulatory & Compliance/
Clear

— OR —

Duration: 90 minutes
On-Demand
Includes handouts
  • Description
  • Who Should Attend
  • What To Expect

Description

COURSE DESCRIPTION

OVERVIEW

Validation of computer systems is a legal requirement within the pharmaceutical, biotech, and medical device industries.  Given the current regulatory and industry focus on electronic data integrity, adequate control over electronic data systems is coming under more scrutiny.  Quality personnel are often tasked with auditing and/or reviewing computer systems validation packages, whether for internal business groups or outsourced businesses that collect or generate regulated data on behalf of the sponsor firm.  Technical management, principal investigators, study directors, and similar personnel can also be tasked with reviewing the adequacy of a system’s validation status prior to approving its use on a regulated activity, but what are the critical items to look for?

The purpose of this training is to present techniques and strategies for auditing computer systems validation documentation for compliance to applicable global regulations, plus internal policies and SOPs.   Current issues including cloud systems and data integrity will be discussed.

LEARNING OBJECTIVES
  1. A review of regulatory requirements for computer systems validation
  2. Understanding the basic components of a computer systems validation package
  3. Identify high-risk areas within a computer systems validation project
  4. Identify where to look in documentation for evidence of specific testing of critical system functions
  5. Learn how to audit change control and periodic review documentation to help assure the maintenance of the validated state
  6. Strategies for reporting and mitigating issues identified
  7. Common mistakes and pitfalls to avoid when auditing your systems

Who Should Attend

WHO SHOULD ATTEND

This course will be of benefit to anyone involved the validation, use, and maintenance of regulated computer systems within GxP environments. This course will be highly-relevant to those in quality assurance, validation, IT, and other job functions responsible for auditing or reviewing the validation, use, and maintenance of computer systems and associated data.

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

Alecia Adams
Helps companies find and implement computerized systems that increase efficiency, sustain compliance, and ease business pain.

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Clear

— OR —

Duration: 90 minutes
On-Demand
Includes handouts

CATEGORIES

  • Coronavirus / COVID-19 (4)
  • Clinical Trials & Good Clinical Practices (GCP) Training (110)
  • Introductory Pharma Courses (18)
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  • 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 EHRs 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

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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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