How to be efficient and compliant with 21 CFR Part 11

By GlobalCompliancePanel (other events)

Wed, Dec 5 2018 8:00 AM Thu, Dec 6 2018 5:00 PM


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.

Course 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



Day 1 Schedule

(8am to 5pm; 0.5 registration, 1.0 lunch, 0.5 (2-15min) breaks, 7.0 class = 9.0 total)

8:00am to 8:30am registration

8:30am class starts

Lecture 1: Introduction to the FDA (1:30) {1:30}

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

Lecture 2: 21 CFR Part 11/Annex 11 - Compliance for Electronic Records and Signatures (4:00) {5:30}

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

Lecture 3: HIPAA Compliance for Electronic Records (0:30) {6:00}

How Part 11 and HIPAA interrelate
What are the additional requirements for patient data

Lecture 4: The Five Keys to COTS Computer System Validation (0:30) {6:30}

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

Lecture 5: The Validation Team (0:30) {7:00}

How to select team members
How to facilitate a validation project

Day 2 Schedule

(9am to 3:30pm; 1.0 lunch, 0.5 (2-15min) breaks, 5.00 class = 6.5 total)

Lecture 6: Ten-Step Process for COTS Risk-Based Computer System Validation (1:00) {1:00}

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).

Lecture 7: How to Write Requirements and Specifications (0:30) {1:30}

Workshop for writing requirements and then expanding them for specifications

Lecture 8: How to Conduct a Hazard Analysis/Risk Assessment-Exercise (0:30) {2:00}

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

Lecture 9: Software Testing (1:00) {3:00}

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

Lecture 10: How to write a Data Privacy Statement (0:30) {3:30}

How to meet the requirements of the EU GDPR

Lecture 11: Purchasing COTS Software (0:30) {4:00}

How to purchase COTS software and evaluate software vendors.

Lecture 12: Cost Reduction Without Increasing Regulatory or Business Risk (1:00) {5:00}

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



David Nettleton

FDA Compliance Specialist,

Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, EU General Data Protection Regulation (GDPR), 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 280 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.


Location:  San Diego, CA Date: December 5th & 6th, 2018 and Time: 8:00 AM to 5:00 PM

Venue:  DoubleTree by Hilton San Diego Downtown 1646 Front St, San Diego, CA 92101, USA



Until October 31, Early Bird Price: $1,295.00 Price: $1,295.00 (Seminar Fee for One Delegate)

From November 01 to December 03, Regular Price: $1,495.00

Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*

Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*

Register now and save $200. (Early Bird)


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