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      Reduce costs for compliance with data integrity

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      November 21, 2019

      Thursday   8:00 AM - 3:30 PM (daily for 2 times)


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      Reduce costs for compliance with data integrity

      Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR


      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.
      It details the requirements for HIPAA Protect Health Information (PHI)
      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).

      Seminar Fee Includes:
      AM-PM Tea/Coffee
      Seminar Material
      USB with seminar presentation
      Hard copy of presentation
      Attendance Certificate
      $100 Gift Cert for next seminar

      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 Objective:

      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 HIPAA expands Part 11 compliance
      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
      Managers and directors
      Software vendors, SaaS hosting providers


      Day 01(8:00 AM - 5:00 PM)

      08.00 AM - 08.30 AM: Registration
      08.30 AM: Session Start
      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 (4 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 compliance: SOPs, software product features, infrastructure qualification, and validation documentation
      How SaaS/cloud computing changes qualification and validation
      Ensure data integrity, security, and protect intellectual property
      Understand the current computer system industry standards for security, data transfer, and audit trails
      Electronic signatures, digital pens, and biometric signatures
      SOPs required for the IT infrastructure
      Product features to look for when purchasing COTS software
      Reduce validation resources by using easy to understand fill-in-the-blank validation documents.
      HIPAA Compliance for Electronic Records (30 Min)
      How Part 11 and HIPAA interrelate
      What are the additional requirements for patient data
      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 facilitate a validation project

      Day 02(9:00 AM - 3:30 PM)

      Ten-Step Process for COTS Risk-Based Computer System Validation (1 hr)
      Learn which documents the FDA expects to audit.
      How to use the risk-based validation approach to lower costs.
      How to link requirements, specifications, risk management, and testing.
      Document a computer system validation project using easy to understand fill-in-the-blank templates.
      Based on: "Risk-Based Software Validation - Ten Easy Steps" (Davis Horwood International and PDA -, 2006).
      How to Write Requirements and Specifications (30 Min)
      Workshop for writing requirements and then expanding them for specifications
      How to Conduct a Hazard Analysis/Risk Assessment-Exercise (30 Min)
      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 to elements of risk management.
      How to write efficient test cases
      How to write a Data Privacy Statement (30 Min)
      How to meet the requirements of the EU GDPR
      Purchasing COTS Software (30 Min)
      How to purchase COTS software and evaluate software vendors
      Cost Reduction Without Increasing Regulatory or Business Risk (1 hr)
      How to save money
      How to increase quality
      How to increase compliance with less documentation


      David Nettleton

      David Nettleton
      FDA Compliance Specialist, Computer System Validation

      Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications.

      He has completed more than 230 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.

      Cost: $1,689

      Categories: Conferences & Tradeshows

      This event repeats daily for 2 times:

      Event details may change at any time, always check with the event organizer when planning to attend this event or purchase tickets.

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