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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Belleville, IL, computer issues quit mailing of sewer costs

Belleville City Hall

Belleville Town Hall

BND

A personal computer difficulty is keeping the town of Belleville from mailing sewer charges to community people or processing automatic debit payments, according to the city’s general public relations professional.

Metropolis Treasurer Sarah Biermann, who handles sewer billing and payments, declined to comment, referring phone calls to PR and Communications Supervisor Kathy Kaiser. The BND questioned Kaiser to make Biermann and Information and facts Technologies Director Scott Markovich out there to reply distinct concerns. She declined.

In accordance to Kaiser, a power surge caused a laptop outage that harmed the city’s billing program, making names and addresses of some clients inaccessible. She explained by means of an emailed assertion to the BND and around the cellphone that an “outside source” has been contracted to “assist in the recovery” of that information.

The city hopes to resolve the problem and concern the remaining expenses by Tuesday, Kaiser said, however she cautioned that time frame could be impacted by the extent of the destruction to the computer software program.

“We did not want to include a timeframe in our statement in scenario it didn’t materialize,” she reported.

She reported no late fees will be assessed for May billing.

Belleville has 42,404 residents and 17,824 homes, in accordance to the final U.S. census. Some of the bills were mailed on time, Kaiser stated, nevertheless she couldn’t say late Friday afternoon how several ended up delayed by the personal computer outage.

Previous June, St. Clair County alerted about 600 citizens that some of their own info may perhaps have been jeopardized by a ransomware attack on the county’s computer system network. The malware infection prompted the county to shut down its pc system and site for quite a few days, beginning Could 30, 2021.

Kaiser claimed the city’s computer system process has not been breached in any way.

Kaiser emailed the subsequent statement:

“The Metropolis of Belleville experienced a laptop or computer outage on April 27. 2022, which resulted in the physical failure of discs attributed to our server. This outage has afflicted our LOCIS Software system, which incorporates our Sewer Billing division.

“Per discussion with our IT section and the outdoors source we have contracted to help in the recovery course of action, this scenario was the consequence of a ability surge to our system, and there is no proof of any malicious attack on our system from outdoors sources.”

The problem grew to become public on Thursday, when the adhering to concept was posted on the Welcome to Belleville Fb web page:

“ATTENTION ALL City Citizens: Owing to a computer system program outage at the Town of Belleville, we have been unable to issue our regular monthly Sewer charges which is why you have not been given them, by means of the US Postal Support. We have also been unable to difficulty immediate debiting for this months expenditures as properly.

“We apologize for any inconvenience this has prompted. We are working diligently to rectify this circumstance, as before

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