2-Day In-Person Seminar

21 CFR Part 11 Compliance for SaaS/Cloud Applications

BY: David Nettleton,

FDA Compliance Specialist, Computer System Validation

June 13-14, 2019
Pyramid Club Philadelphia, PA
  • Course Description
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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 will Benefit:
  • GMP, GCP, GLP, regulatory professionals
  • QA/QC
  • IT
  • Auditors
  • Managers and directors
  • Software vendors, 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 - Compliance for Electronic Records and Signatures (4 hr)
    • What Part 11 means to you, not just what it says in the regulation.
    • 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.
  • 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(8:30 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 - www.pda.org, 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.

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$1,499.00

Seminar One Registration

June 13-14, 2019, Philadelphia, PA
(Registrations till April 30, 2019 - $1499)
(Registrations after April 30, 2019 - $1699)


Your registration fee includes the workshop, all course materials and lunch.
For discounts on multiple registrations, contact customer care at +1-888-771-6965.

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Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-771-6965 or email us @ customercare@fdatrainingalert.com

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Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)

Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $300 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future FDATrainingAlert event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

In the event FDATrainingAlert cancels the seminar, FDATrainingAlert is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

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How to Reach »
Driving directions from Philadelphia International Airport - 9.2 miles:
  • Get on PA-291 E/Penrose Ave from Garage Access Rd and Exit 13.
  • Continue on PA-291 E/Penrose Ave.
  • Take S 26th St and I-76 W to N 18th St. Destination will be on the right.
Select hotels close to meeting venue:
  • 300 feet | 1 min walk | Sonesta Philadelphia Downtown Rittenhouse Square | 1800 Market St, Philadelphia, PA 19103 | sonesta.com | (215) 561-7500
  • 0.2 mi | 4 min walk | Hotel Sofitel Philadelphia | 120 S 17th St, Philadelphia, PA 19103 | accorhotels.com | (215) 569-8300
  • 0.1 mi | 3 min walk | The Westin Philadelphia | 99 South 17th Street at Liberty Place, Philadelphia, PA 19103 | westinphiladelphiahotel.com | (215) 563-1600

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.

See What People Say About Us

Really good location with good lunch. This seminar was full of valuable topics.

System Admin, IT

This is my first experience with ComplianceOnline and I would definitely attend other seminars.

Business System Analyst

It was a knowledgeable seminar. Thanks for inviting me. I will attend upcoming seminars on ISO 13485 and Sterilization validation.

Director of Quality

I love to receive your email alerts. It keeps me updated with all valuable trainings. You have variety of offerings.

Test Engineer

All topics were informative and interesting. Database validation was the most valuable topic for me as I was hired for this job function. David is excellent and personable speaker; his knowledge and experience provide credibility and exceptional insight. Overall it was a wonderful event. Excellent choice of venue, materials and food was arranged by ComplianceOnline!!!

Software and Training Support Specialist

Thanks ComplianceOnline. Your website is very accessible and communicates well. It covers many compliance topics. For this seminar venue was convenient for west cost. Sometimes I cannot travel so attend those trainings online.

Director, Validation

David is an excellent instructor, very animated and has a great energy level. He was able to really engage with the attendees.

Business System Analyst

David is one of the best presenters I have seen. This subject was well presented by him.

Manager, IT

A former attendee of this seminar referred me. David was great with shuns while keeping everybody engaged.

VP Global CRM & Business Solutions

It was a great seminar. I like the topic Hazard/Risk Assessment. I do all other validation activities as David presented but didn't evaluate my specs for Risk but I can really see how this will benefit the whole validation process and am definitely adding it.

Business System Analyst, Documentation

I literally don't have any suggestions to improve your future seminars. I just love it. The presenter was very entertaining and informative.

Test Engineer

Thanks for coordinating this seminar. Customer service was very good, event was well arranged and good meal was a plus.

Sr. Manager, IT

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For more details and other sponsorship options at this event, please contact Event Manager: customercare@fdatrainingalert.com or call: +1-650-238-9656

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