Business course

Two-Day Virtual Course: Reducing Data Integrity Compliance Costs: 21 CFR Part 11, SaaS/Cloud, EU GDPR – July 19-20, 2022 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Reduce Data Integrity Compliance Costs: 21 CFR Part 11, SaaS/Cloud, EU GDPR” training has been added to from ResearchAndMarkets.com offer.

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

  • It details the requirements of Part 11 and Annex 11: SOP, software product functionality, infrastructure qualification and validation.

  • The instructor covers the latest computer systems 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 on-premises and SaaS/cloud hosting solutions.

  • Almost all computerized systems used in laboratories, clinics, manufacturing and the quality process must be validated. Participants learn how to reduce software implementation time and cost by using a 10-step risk-based approach to validating IT systems.

  • The instructor reviews recent FDA inspection trends and explains how to streamline document creation, review, 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 who uses computer systems to perform their professional tasks and is ideal for professionals working in the healthcare, clinical trials, biopharmaceutical and medical device industries. It is essential for software vendors, auditors and quality personnel involved in GxP applications.

Learning objectives:

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

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

  • Understand what is expected from Part 11 and Schedule 11 inspections in order to be prepared

  • Avoid 483 and Warning Letters

  • Understand the specific responsibilities and tasks of your staff, including IT and quality assurance

  • Understand your responsibilities and obligations when using SaaS/cloud

  • Learn how to perform risk-based IT system validation using fillable templates

  • How to select resources and manage validation projects

  • “Right-size” change control methods that enable fast and safe system evolution

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

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

  • Learn how to comply with data privacy requirements

  • Learn how to purchase COTS software and qualify suppliers

  • Protect intellectual property and keep electronic records safe

Main topics covered:

Day 01 (9:00 a.m. – 3:00 p.m. PDT)

  • Introduction to the FDA (1h)

    • How regulation helps your business succeed

    • What data and systems are subject to Part 11.

  • 21 CFR Part 11/Annex 11 – Compliance with Electronic Records and Signatures (3h30)

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

    • Avoid 483 and Warning Letters

    • Explore the four main areas of Part 11 compliance: SOPs, software product functionality, infrastructure qualification, and validation documentation

    • How SaaS/cloud computing changes qualification and validation

    • Ensure data integrity and security and protect intellectual property

    • Understand current IT systems industry standards for security, data transfer, and audit trails

    • Electronic signatures, digital pens and biometric signatures

    • IT Infrastructure Required SOPs

    • Product Features to Look for When Purchasing COTS Software

    • Reduce validation resources by using easy-to-understand validation documents.

  • The Five Keys to COTS Computer System Validation (30 min)

    • The who, what, where, when and why of CSV

  • The validation team (30 min)

    • How to select team members

    • How to lead a validation project

Day 02 (9:00 a.m. – 3:00 p.m. PDT)

  • Ten-Step Process for COTS Risk-Based Computer System Validation (1:30 hrs)

    • Find out which documents the FDA plans to review.

    • How to use the risk-based validation approach to reduce costs.

    • How to link requirements, specifications, risk management and testing.

    • Document an IT system validation project with easy-to-understand fillable templates.

    • Based on: “Risk-Based Software Validation – Ten Easy Steps” (Davis Horwood International and PDA

  • How to write requirements and specifications (30 min)

    • Workshop for writing the requirements then their extension for the specifications

  • How to Conduct a Hazard Analysis/Risk Assessment Exercise (30 mins)

    • Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation.

  • Software testing (1 hr)

    • Reduce testing by writing test cases that trace the elements of risk management.

    • How to write effective test cases

  • How to Write a Data Privacy Statement (30 mins)

    • How to meet EU GDPR requirements

  • Buy COTS software (30 min)

    • How to Buy COTS Software and Evaluate Software Vendors

  • Reducing Costs Without Increasing Regulatory or Business Risks (1 hr)

    • How to save money

    • How to increase the quality

    • How to increase compliance with less documentation

For more information on this training, visit https://www.researchandmarkets.com/r/6z11i5