PRE-REGISTRATION AVAILABLE If you want to have this training scheduled Live and Exclusively for your company, we will arrange it for you. Pre-Register now and pay only once the training is scheduled on your preferred days. Click on the button below to pre-register

Faculty: CAROLYN TROIANO

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Description

PRE-REGISTRATION AVAILABLE

If you want to have this training scheduled Live and Exclusively for your company, we will arrange it for you.

Pre-Register now and pay only once the training is scheduled on your preferred days.

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.

SEMINAR OBJECTIVES		WHO SHOULD ATTEND
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		GMP, GCP, GLP, regulatory professionals QA/QC Departments IT Departments Engineering Departments Validation Departments Documentation Departments Manufacturing Departments Production Departments Operations Departments Auditors Departments Managers and directors Departments Software vendors, hosting providers

AGENDA

DAY 1 (9 AM to 3 PM Pacific Time)

09:00 AM - 10:00 AM: Introduction to the FDA

How the regulations help your company to be successful
Which data and systems are subject to Part 11

10:00 AM - 02:00 PM: 21 CFR Part 11/Annex 11 - Compliance for Electronic Records and Signatures

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

* Includes two 10 minute breaks and a 40 Minute Lunch break

02:00 PM - 02:30 PM: The Five Keys to COTS Computer System Validation

The Who, What, Where, When, and Why of CSV

02:30 PM - 03:00 PM: The Validation Team

How to select team members
How to facilitate a validation project

DAY 2 (9 AM to 3 PM Pacific Time)

09:00 AM - 10:30 AM: Ten-Step Process for COTS Risk-Based Computer System Validation

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 - www.pda.org, 2006)

* Includes a 10 Minute break

10:30 AM - 11:00 AM: How to Write Requirements and Specifications

Workshop for writing requirements and then expanding them for specifications

11:00 AM - 12:00 PM: How to Conduct a Hazard Analysis/Risk Assessment-Exercise

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

12:00 PM - 01:15 PM: Software Testing

Reduce testing by writing test cases that trace to elements of risk management.
How to write efficient test cases

* Includes a 40 Minute Lunch Break

01:15 PM - 02:00 PM: How to write a Data Privacy Statement

How to meet the requirements of the EU GDPR

* Includes a 10 minute break

02:00 PM - 02:30 PM: Purchasing COTS Software

How to purchase COTS software and evaluate software vendors

02:30 PM - 03:00 PM: Cost Reduction Without Increasing Regulatory or Business Risk

How to save money
How to increase quality
How to increase compliance with less documentation

Course Directors: DAVID NETTLETON

David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is “Risk Based Software Validation – Ten easy Steps” that relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 185 mission critical software validation projects.

21 CFR Part 11 Data Integrity Training for SaaS/Cloud, EU GDPR - How to Reduce Costs for Compliance

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AGENDA

Course Directors: DAVID NETTLETON

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