Final Days to Register: 2 Day Interactive Risk-based Computer System Validation Course: Reduce Costs and Avoid 483

DUBLIN, Sept. 26, 2022 /PRNewswire/ — The “Risk-based Computer System Validation; Reduce Costs and Avoid 483” training has been added to ResearchAndMarkets.com’s offering.

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This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments.

  • It details the requirements for Part 11 and Annex 11: SOPs, software product features, infrastructure qualification, and validation.

  • The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation.

  • Understand the specific requirements associated with local and SaaS/cloud hosting solutions.

  • Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated. Participants learn how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation.

  • The instructor reviews recent FDA inspection trends and discusses how to streamline document authoring, revision, review, and approval.

  • Participants will learn how to write a Data Privacy Statement to comply with the EU General Data Protection Regulation (GDPR).

  • This course benefits anyone that uses computer systems to perform their job functions and is ideal for professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GxP applications.

Learning Objectives:

  • Reduce costs, usually by two-thirds, for compliance with electronic records

  • Learn how to use electronic records and electronic signatures to maximize productivity

  • Understand what is expected in Part 11 and Annex 11 inspections so you are prepared

  • Avoid 483 and Warning Letters

  • Understand the responsibilities and specific duties of your staff including IT and QA

  • Understand your responsibilities and liabilities when using SaaS/cloud

  • Learn how to perform risk-based Computer System Validation using fill-in-the-blank templates

  • How to select resources and manage validation projects

  • “Right size” change control methods that allows quick and safe system evolution

  • Minimize validation documentation to reduce costs without increasing regulatory or business risk

  • Learn how to reduce testing time and write test cases that trace to elements of risk management

  • Learn how to comply with the requirements for data privacy

  • Learn how to buy COTS software and qualify vendors

  • Protect intellectual property and keep electronic records safe

Who will Benefit:

  • GMP, GCP, GLP, regulatory professionals

  • QA/QC

  • IT

  • Auditors

  • Managers and directors

  • Software vendors, SaaS hosting providers

Who Should Attend:

  • GMP, GCP, GLP, regulatory professionals

  • QA/QC

  • IT

  • Auditors

  • Managers and directors

  • Software vendors, SaaS hosting providers

Key Topics Covered:

DAY 01 (9:00 AM – 3:00 PM PDT)

  • Introduction to the FDA (1 hr)

  • How the regulations help your company to be successful

  • Which data and systems are subject to Part 11.

  • 21 CFR Part 11/Annex 11 – Compliance for Electronic Records and Signatures (3:30 hr)

  • What Part 11 means to you, not just what it says in the regulations

  • Avoid 483 and Warning Letters

  • Explore the four primary areas of Part 11

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Doja Cat’s ‘Woman’ Is Now an Interactive Tunes Video clip with a Codable Knowledge to Master About Programming




Doja Cat Woman Interactive Music Video to Teach about Programming
(Photograph : Ladies Who Code)

Doja Cat’s audio movie for “Woman” is turned into an interactive expertise that focuses on laptop or computer code where folks can understand about programming as they go on to direct the upcoming scenes, and additional. The venture was introduced by an business regarded as “Women Who Code,” and its most important advocacy is to teach girls about programming and introduce the self-control to them for their upcoming professions.

Doja Cat’s ‘Woman’ Is Now an Interactive Tunes Movie with a Codable Expertise

According to a release by Women Who Code via Twitter, a new interactive system that makes use of the “Girl” music video clip by well known American rapper, singer, and songwriter, Doja Cat. The expertise would just take a person to “coding,” the regarded approach of executing pc instructions and programming to make apps and other kinds of plans executable or working.

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Here, people today will find out about pc programming while tuning into the conquer of a single of the most well-liked tunes from the album, “Planet Her.” The interactive music video clip is a codable experience, where individuals will execute personal computer codes to change this into that, transforming some factors in the visuals and audio in which 1 can find out and apply.

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Women Who Code: Training Ladies about Programming by way of Doja Cat

The working experience is readily available through “dojacode.com” and it is no cost for everybody to use and make use of to study about programming and the like.

Having said that, the primary target of Girls Who Code is to instruct gals the ins and outs of laptop or computer programming, hoping to invite persons into studying or using up this discipline quickly. The non-income corporation aims to unfold the awareness of laptop or computer programming, demonstrating yet another aspect to it with a hint of creativeness.

Pop Culture and Laptop Programming

Pop tradition (well-liked) has been a huge entity in the mass media in the planet these days, concentrating on viral memes and viral TikTok challenges where people today get into and join the trend.

On the other hand, computer programming is not that famous in the actual world, as folks that get into it are known for their skills and interest in the earth of pcs and know-how.

Having said that, like all factors, it can be realized and practiced as early as now for the long run and its improvement, consequently making more alternatives for the self-discipline for all that aspires to be a programmer. The growth by Women Who

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