2 Days In-Person Seminar (Code – GRCSEM-6235)

2 Days - Data Integrity: compliance with 21 CFR Part 11, Annex 11, SaaS/Cloud, and EU GDPR

David Nettleton

Leader, Author and Teacher for 21 CFR Part 11

March 05 & March 06, 2019

Phoenix, Arizona

Click here to download a Registration FormRegistration Form

 

Topic Description: 

  • 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).
  • 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 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 can Attend: 

  • GMP, GCP, GLP, regulatory professionals
  • QA/QC
  • IT
  • Auditors
  • Managers and directors
  • Software vendors, SaaS hosting providers

Next Online and Two Day Events: 

Online: 21 CFR Part 11 Data Integrity: How to Validate Software for SaaS/Cloud, EU, GDPR

Online: Excel Spreadsheet Validation-Step by Step Guide to Data Integrity Compliance

March 05 and 06, 2019: 2 Days - Data Integrity: compliance with 21 CFR Part 11, Annex 11, SaaS/Cloud, and EU GDPR

March 07, 2019: One Day Workshop - Excel Spreadsheet Validation-Step by Step Guide to Data Integrity Compliance

Instructor:

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 270 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.

Services are available to guide companies to create and maintain the systems and procedures required to pass regulatory inspections: product features, vendor audits, software validation, SOPs, training, gap analysis, remediation plans, and project management.

Projects involve: medical devices, blood bank, clinical trial, corrective action, document control, electronic data capture, Excel spreadsheets, laboratory instruments, laboratory information management (LIMS), manufacturing, enterprise resource planning, toxicology systems, and VMWare.

David Nettleton is also the co-author of:

  • Managing the Documentation Maze – Answers to Questions You Didn’t Even Know to Ask Wiley 2010
  • Electronic Record Keeping; Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164 (Interpharm/CRC 2004)
  • Commercial Off-the-Shelf (COTS) Software Validation for 21 CFR Part 11 Compliance (Davis Horwood International and PDA 2003).

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 270 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.

Services are available to guide companies to create and maintain the systems and procedures required to pass regulatory inspections: product features, vendor audits, software validation, SOPs, training, gap analysis, remediation plans, and project management.

Projects involve: medical devices, blood bank, clinical trial, corrective action, document control, electronic data capture, Excel spreadsheets, laboratory instruments, laboratory information management (LIMS), manufacturing, enterprise resource planning, toxicology systems, and VMWare.

David Nettleton is also the co-author of:

  • Managing the Documentation Maze – Answers to Questions You Didn’t Even Know to Ask Wiley 2010
  • Electronic Record Keeping; Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164 (Interpharm/CRC 2004)
  • Commercial Off-the-Shelf (COTS) Software Validation for 21 CFR Part 11 Compliance (Davis Horwood International and PDA 2003).



Click here to download a Registration FormRegistration Form

 

Location: Phoenix, Arizona

Hotel: Venue will be announced by 31st of January, 2019 | Top 10 Things to do in Phoenix, Arizona - Click Here

Available Options

Fee for One Single Participant - 2 Days

$1,245

Fee for Two Participants - 2 Days

$2,245

Fee for Three Participants - 2 Days

$3,375

Fee for Four Participants - 2 Days

$4,495

Fee for Five Participants - 2 Days

$5,625

Fee for Eight Participants - 2 Days

$7,995

Fee for Ten Participants - 2 Days

$9,995

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