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HomeManufacturing (GMP)How to Prepare for FDA Guidance on Computer Software Assurance (CSA) in 2021 – A Two Part Primer

How to Prepare for FDA Guidance on Computer Software Assurance (CSA) in 2021 – A Two Part Primer

Teachers
Kathleen Warner
Category:
IT & Data Integrity for Pharma/ Leadership & Training/ Manufacturing (GMP)/ Medical Device Training/ On-Demand Courses/ Quality/ Regulatory & Compliance/ Research & Development/
Clear

— OR —

Duration: 120-Minutes (Two 60-minute sessions)
On-Demand
Includes handouts!

This course is a two-part series, with 60-minute webinars on two separate days.

  • Description
  • Who Should Attend
  • What To Expect

Description

COURSE DESCRIPTION

OVERVIEW

In 2011 the Center for Devices and Radiological Health (CDRH) initiated the Case for Quality, a new program that identified barriers in the current validation of software in medical devices guidance (released in 2002). Now, CDRH — in cooperation with the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) — is preparing to release new guidance, Computer Software Assurance (CSA) for Manufacturing, Operations and Quality Systems Software, recently delayed until February 2021.

As pharmaceutical companies perfected their business processes and became more efficient in validating computer systems, the piles of documentation continued to grow without significant quality benefits. The focus was on speed, documentation accuracy and completeness, inspections, audits, and complying with the regulation.

Transitioning to the new guidance will require unlearning “the old,” and relearning how to apply CSA. The emphasis is on critical thinking, risk management, patient and product safety, data integrity, and quality assurance. Even though this guidance is being developed for the medical device industry, the FDA has indicated it should be considered when deploying non-product, manufacturing, operations, and quality system software solutions, such as quality management systems (QMS), enterprise resource planning (ERP) systems, laboratory information management systems (LIMS), learning management systems (LMS), and electronic document management systems (eDMS).  As such, the guidance will be applicable to research and development (R&D), clinical, laboratory, and other groups within pharmaceutical, biopharmaceutical, and medical device companies that are currently meeting the regulations for electronic records and electronic signatures (ERES) and computer system validation (CSV).

This two-part webinar will give you a foundation for understanding the guidance, if (and how) it is right for you, and steps to practically assess benefits and apply the guidance. Session one will provide definitions on critical thinking, risk management, patient and product safety, data integrity, and quality assurance. Session two focuses on how to transition from CSV to CSA leveraging CSV methodology, business processes, and risk management.

LEARNING OBJECTIVES (SESSION ONE)

At the completion of this session, you will be able to:

  • Explain the differences between Computer System Validation (CSV) and Computer Software Assurance (CSA) and short- and long-term benefits of moving to CSA
  • Define and discuss key terms and concepts being introduced with CSA to include critical thinking and risk management
  • Define and discuss patient and product safety, data integrity, and quality assurance
  • Build foundational knowledge required to transition from CSV to CSA
LEARNING OBJECTIVES (SESSION TWO)

At the completion of this session, you will be able to:

  • Recap learnings from Webinar Part 1 – the differences between Computer System Validation (CSV) and Computer Software Assurance (CSA); and short- and long-term benefits; terms and definitions; and patient and product safety, data integrity, and quality assurance
  • Provide an approach to plan for CSA transition to include people, process, technology and product.
  • Develop quality metrics (qualitative and quantitative) on organizational performance: people, process, project and technology
  • Create a Transition Plan – with a phased road map for a successful transition to CSA

Who Should Attend

WHO SHOULD ATTEND

This course will be of benefit to anyone working in a regulated environment on a domestic scale that is part of the team that performs, reviews and approves Manufacturing, Operations and Quality Systems Software, as well as non-product, manufacturing, operations, and quality system software solutions. This includes personnel in:

  • Clinical Operations
  • Engineering
  • Information Technology
  • Legal Counsel
  • Manufacturing
  • Quality
  • Other functions that may be subject to CDRH and FDA regulations

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 and use Option 3 (9am – 5pm EST, M-F) for assistance.

About Instructors

Kathleen Warner
Kathleen Warner, Ph.D., VP of Consulting Services for RCM Technologies, Life Sciences, is an executive consultant with 25+ years of experience in information technology (IT) and the life sciences.

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Clear

— OR —

Duration: 120-Minutes (Two 60-minute sessions)
On-Demand
Includes handouts!

CATEGORIES

  • Coronavirus / COVID-19 (4)
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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

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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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