How to be Efficient and Compliant with Part 11, Validation

By GlobalCompliancePanel (other events)

Mon, Feb 4 2019 8:00 AM Tue, Feb 5 2019 5:00 PM


This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.
Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers.
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.
Today the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance.
This seminar will help you 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.
Finally, the instructor reviews recent FDA inspection trends and discusses how to streamline document authoring, revision, review, and approval.
This course benefits anyone that uses computer systems to perform their job functions and is ideal for regulatory, clinical, and IT 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:

Understand what is expected in 21 CFR Part 11 and Annex 11 inspections
Avoid 483 and Warning Letters
Learn how to buy COTS software and qualify vendors.
Implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds
Requirements for local, SaaS, and cloud hosting
How to select resources and manage validation projects
"Right size" change control methods that allows quick and safe system evolution
Minimize the validation documentation to reduce costs without increasing regulatory or business risk
Write test cases that trace to elements of risk management
Protect intellectual property and keep electronic records safe





Day 1 Schedule

Day 1 (8am to 5pm; 0.5 registration, 1.0 lunch, 0.5 (2-15min) breaks, 7.0 class = 9.0)
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 three primary areas of Part 11 compliance: SOPs, software product features, 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: 
The Five Keys to COTS Computer System Validation (0:30) {6:30}

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

Lecture 4: 
The Validation Team (0:30) {7:00}

How to select team members
How to facilitate a validation project

Day 2 Schedule

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


Lecture 5: 
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 6: 
How to Write Requirements and Specifications (0:30) {1:30}

Workshop for writing requirements and then expanding them for specifications


Lecture 7: 
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 8: 
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 9: 
System Change Control (0:30) {3:30}

How to manage a validated system with minimal documentation

Lecture 10: 
Purchasing COTS Software (0:30) {4:00}

How to purchase COTS software and evaluate software vendors.

Lecture 11: 
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


Carolyn Troiano

Consultant, BrainStorm Central Consulting

Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

Location:  Boston, MA Date: February 4th & 5th, 2019 and Time: 8:00 AM to 5:00 PM

Venue:  Four Points by Sheraton Boston Logan Airport Revere, MA 407 Squire Rd, Revere, Massachusetts 02151, United States



1 ATTENDEE $1,295, You Save: 00 (00%)* Regular Price: $1200, Register for 1 attendee

5 ATTENDEES $3,885, You Save: $2,590, (40%)* Regular Price: $6,475, Register for 5 attendees

10 ATTENDEES $7,122, You Save: $5,828, (45%)*Regular Price: $12,950, Register for 10 attendees

Until December 31, Early Bird Price: $1,295.00 
From January 01 to February 02, Regular Price: $1,495.00


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