Tag: Validation

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

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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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Pc System Validation (CSV) and Information Integrity for Scientific Trials Controlled by Food and drug administration System (Oct 13-14, 2022)

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

DUBLIN, Sept. 26, 2022 /PRNewswire/ — The “Laptop Method Validation (CSV) and Info Integrity for Scientific Trials Regulated by Fda Study course” training has been included to  ResearchAndMarkets.com’s featuring.

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Computer method validation has been controlled by Fda for far more than 30 yrs, as it relates to methods used in the manufacturing, testing, and distribution of a solution in the pharmaceutical, biotechnology, health-related gadget, or other Fda-regulated industries. The Fda needs make certain extensive organizing, implementation, integration, screening, and management of computer systems utilized to gather, evaluate and/or report details.

Electronic data and electronic signatures (ER/ES) came into perform by means of pointers founded by Fda in 1997 and disseminated by 21 CFR Portion 11. This code describes the essential requirements for validating and documenting ER/ES functionality in techniques employed in an Food and drug administration-regulated setting.

FDA’s current concentrate on details integrity through laptop or computer procedure validation inspections and audits has introduced this situation to the forefront of importance for compliance of techniques applied to assistance medical trials. These involve medical demo data selection, administration and reporting techniques, clinical demo sample manufacturing, tests and labeling programs, and all of these systems utilized in the conduct of the scientific demo which generates documentation for the scientific Demo Grasp File (TMF).

Why Should You Attend this virtual seminar?

We will examine the most effective tactics and strategic ways for assessing computer system methods made use of in the perform of medical trials and analyzing the degree of compliance, based mostly on validation and info integrity. We will stroll by the complete Procedure Progress Daily life Cycle (SDLC) strategy to validation of Food and drug administration-regulated computer system methods, and will also go over 21 CFR Element 11 and the great importance of controlling digital information and signatures correctly.

We will also walk by means of the total established of critical medical trial documents that must be maintained just before, throughout, and right after completion of the demo in the Demo Grasp File (TMF). This element of the dialogue will also delve into the use of electronic Demo Master File (eTMF) techniques and the pros and downsides of executing so.

At last, we will discuss what is needed to prepare for an Food and drug administration inspection of computer system programs and info used in assistance of clinical trials. These are extremely beneficial belongings for any enterprise doing this sort of operate, and very best endeavours are vital to make sure info is preserved in a state of integrity throughout its lifecycle.

Understanding Objectives

  • Master how to identify “GxP” Techniques

  • Talk about the Laptop Method Validation (CSV) strategy centered on Food and drug administration demands

  • Learn about the Procedure Progress Lifetime Cycle (SDLC) approach to validation

  • Explore the most effective procedures for documenting laptop or computer technique validation efforts, including requirements, style, development, screening, and operational routine maintenance techniques

  • Comprehend how to keep a system in a validated point out through the system’s full life cycle

  • Learn

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