Course Description:

This interactive two-day course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. 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.

Many companies outsource IT resources and are involved in 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 to avoid FDA form 483s and Warning Letters.

This course is intended for these regulated companies, software vendors, and SaaS/cloud providers. The seminar instructor will:

  • Address the latest computer system industry standards for data security,data transfer, audit trails, electronic records and signatures, software validation, and computer system validation.
  • Help participants understand the specific requirements associated with local and SaaS/cloud hosting solutions.
  • Illustrate the importance of validating the quality process and every computerized system used in laboratory, clinical, and manufacturing settings.
  • Demonstrate how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation.
  • Review recent FDA inspection trends and discuss how to streamline document authoring, revision, review, and approval.


Learning Objective:

  • Understand what is expected in Part 11 and Annex 11 inspections
  • Avoid 483s 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

Interview with
David Nettleton, FDA Compliance Specialist


Who will Benefit:

This course will benefit all who use 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.

  • Regulatory Affairs
  • QA/ QC
  • IT/IS
  • Software Managers
  • Project Managers
  • Software vendors and suppliers

Seminar Fee Includes:

Lunch
AM-PM Tea/Coffee
Seminar Material
Soft copy of presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar




Course Outline:

Day One (8:00 AM – 5:00 PM) Day Two (8:00 AM – 4:00 PM)

Registration Process: 8:00 AM – 8:30 AM

Session Start Time: 8:30 AM

  1. Introduction to the FDA
    2. Interactive discussion that builds the foundation for electronic records:
    • Why the FDA regulates.
    • How the regulations work together.
    • Introduction to Part 11.
    • Predicate rules.
    • FDA and international standards.
    • GAMP.
  2. 21 CFR Part 11 - Compliance for Electronic Records and Signatures
    3. Interactive discussion that details the regulation and how it applies to computerized systems. What makes this session unique is the understanding of how the concepts of Part 11 affect industry standards related to computer systems.
    • Which data and systems are subject to Part 11.
    • What Part 11 means, not just what it says.
    • Avoid 483 and warning letters.
    • Examine the regulatory requirements for the four primary areas of Part 11 compliance: SOPs, software product features, infrastructure qualification, and validation documentation.
    • Ensure data integrity and protect intellectual property.
    • Evaluate the regulatory requirements for security, data transfer, audit trails, electronic signatures, digital pens, and biometric signatures.
    • SOPs required for the IT infrastructure.
    • Requirements for SaaS and cloud hosting.
    • Product features to look for when purchasing COTS software.
    • Reduce validation resources by using easy to understand fill-in-the-blank validation documents.
    • Overview of the developer and user validation models.v
  3. The Five Keys to COTS Computer System Validation
    4. Interactive discussion of the fundamentals of user validation for Commercial Off-The-Shelf (COTS) software as required by 21 CFR Part 11. What makes this session unique is the complexity of the topic is restated in terms everyone can understand.
    • Apply the Who, What, Where, When, and Why of risk-based computer system validation.
    • Understand the real life common errors and how to avoid them.
    • Reduce staff resources, documentation, and project timelines.
    • Real life examples to ensure success.
    • Recommendations for performing efficient validation projects.
    • How to use resources effectively.
    • Increase compliance while lowering costs.
  4. Selecting a Validation Team That Is Effective
    5. Interactive discussion that describes how to assemble a validation team for maximum productivity and most efficient use of resources. What makes this session unique is the experience of completing more than 185 validation projects provides proof that you can create an effective team by using techniques that are known to work well.
    • Members.
    • Team characteristics.
    • How to facilitate and how to lead.
    • How to get the right people to work together so validation is efficient and takes only one-third the time.
  5. Ten-Step Process for COTS Computer System Validation – Reduce Time and Costs
    6. Interactive discussion of the templates used to create validation documentation, usually saving two-thirds of the time and costs. What makes this session unique is the experience of many teams using the same approach comes to the same conclusion, that the 10-step process is highly effective and understandable.
    • 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).
    • Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation.
    • Reduce testing by writing test cases that trace to elements of risk management.
  1. How to Write Requirements and Specifications
    2. Workshop exercises that teach how to write a requirement and then build upon it to write a specification. What makes this session unique is the hands on experience of authoring as a team.
    • How requirements and specification differ.
    • What they have in common.
    • How to author as a team.
    • Workshop exercises.
  2. How to Conduct a Hazard Analysis/Risk Assessment
    3. Workshop exercises that teach how to determine and document risk in a process in order to reduce validation time and ensure compliance. What makes this session unique are the real life examples that make application of the techniques understandable in the context of any validation project.
    • Interactive real life examples.
    • How to identify risk and establish mitigations.
    • How to use the hazard analysis to make validation efficient.
    • How risk assessment reduces validation time.
    • Determine risk in a process to reduce the testing effort.
    • Workshop exercises.
  3. Software Testing – How to Reduce Time and Costs
    4. Interactive discussion that details the role of testing within the risk-based validation approach in order to reduce time and costs while ensuring process controls. What makes this session unique is the experience of completing more than 185 validation projects provides proof that you can use techniques that are known to significantly reduce time and costs.
    • Testing concepts and tools for efficient testing.
    • Static vs. dynamic test methods.
    • How to perform and document testing.
    • How to track bugs and issues during testing.
    • How to use testing to verify system acceptance without testing everything.
    • Proven techniques for reducing testing time and documentation while improving defect detection.
    • How to efficiently write and execute test cases.
    • How to develop the testing protocol.
    • How to reduce testing to one-third the time.
    • It concludes with an array of testing strategies that improve quality and reduce testing time.
  4. System Change Control – Reduce Maintenance Time and Costs
    5. Interactive discussion that leverages the 10-step risk-based validation approach to make revalidation efficient and understandable. What makes this session unique is the experience of completing more than 185 validation projects provides proof that you can use techniques that are known to significantly reduce time and costs.
    • How to “right size” change control methods that allow quick and safe system evolution while maintaining the validated state.
    • How to identify, document, and process changes to computer systems.
    • Proven techniques for categorizing and processing changes so that quality is improved and overhead is reduced.
    • Explore all types of changes: hardware changes, software upgrades, operating system upgrades, and configuration changes.
    • How to make changes, perform revalidation, and update documentation to maintain an evolving compliant system.
    • How to avoid problems related to computer systems when changes are made.
    • How to work with issues during development or during use of the systems.
    • Avoid 483s associated with insufficient documentation of changes and testing.
    • How to continually make changes and maintain compliance.
    • How to use change control to keep maintenance costs low.
    • How to develop a change control plan that satisfies all parties with minimal documentation.
  5. Cost Reduction Without Increasing Regulatory or Business Risk
    6. Interactive discussion that summarizes the proven techniques that reduce validation project time, often to one-third. What makes this session unique is the compilation of proven techniques that are not obvious until understood in the context of the work being performed. It is especially good for management and executives.
    • Proven techniques that reduce software costs and implementation times.
    • Increase corporate productivity and individual workforce member productivity.
    • How to use COTS software to lower costs.
    • Efficiently create validation documentation.
    • Decrease resource requirements.
    • Make documentation more manageable and understandable.
    • Avoid 483s and warning letters.
    • How to use the help desk.
    • How to load data.
    • How to reduce the number of systems.
    • How to integrate systems.
    • How to use VMware to lower costs.
    • Increase compliance and demonstrate how to use risk management to improve system performance and promote process improvement.
    • How to implement a computer system to gain maximum productivity.
    • Use resources effectively to perform effective validation while avoiding doing too much.
    • Understand software vendor claims and the deficiencies of their validation packages.




Meet Your Instructor

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.

 
Interview with
David Nettleton, FDA Compliance Specialist



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Testimonials

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

I am more confident about ability to carry out Computer System Validation. David provides Comprehensive information in a way that makes sense. He's patient, passionate about what he does, and provides great examples! Thank You, David!
- Director Technical Services

Thank you ComplianceOnline. Staff was very supportive, good choice of topic and content. Everything was valuable there. Thanks again!
- Director, Agile Systems and Processes

You made the Complex Simple!!!
- Business Systems Manager

It’s Great!!! The low and courts approach really put a new perspective on validation. The FDA isn't who you should be worried about.
- Project Engineer

Lots of information provided during the seminar. Not presented in 'Traditional' Validation training. Not Cook Book.
- Software Quality Assurance

Loved David's opinions - Made it a rich event. My suggestion to improve future events "please don't change a thing". Very best wishes!!!
- Global Quality Operations Analyst

David helped us make our software development process efficient and helped us to understand how the regulations affect our customers.
- Software Vendor, Vancouver, BC

Thanks for finding me and giving me the opportunity to take this session. I like all the topics, especially 21 CFR Part II Compliance. David Nettleton is a phenomenal instructor. The amount of interaction between the participants and presenters is ideal which help us to explore more. I would strongly recommend this seminar.
- Technical Writer

I can tell David has a lot of experience with computer system validation because David bridged the gap between IT, QA, and Clinical.
- Contract Research Organization, Los Angeles, CA

After we attended David's training, we implemented the procedures he recommended, and we just had our first FDA inspection with no 483s.
-Pharmaceutical company, San Francisco, CA

I really enjoyed the class. I thought the information that David Nettleton gave us was real world examples of the way Computer System Validation should be done. I have suggested to a few of my colleagues to review the information that we were given at the Computer System Validation Reduce Costs and Avoid 483.
- Lisa Wyeth

This was one of, if not the best, most informative, enjoyable trainings I've attended in my 11 year GMP career and I have been to many. David was simply an outstanding presenter. In this class, there was much participation and people learn from other's questions. Overall I had a very positive experience and brought back value to my company.
- Lead Auditor

I enjoyed the seminar very much. I am hoping to be able to implement some of the things I learned in my own work efforts. I thought David was an excellent facilitator and he kept the pace moving along properly to cover all of the material in time.
- Sr. Validation Engineer

I thoroughly enjoyed the seminar! The content of the seminar was excellent.
- Associate Director

Seminar was very interactive and applied real time instances. 10 step process and Hazard Analysis were the most valuable topics for me. The support materials are very useful.
- QA/RA Manager

I enjoyed the seminar very much. I am hoping to be able to implement some of the things I learned in my own work efforts. I thought David was an excellent facilitator and he kept the pace moving along properly to cover all of the material in time. If I had one criticism, it would be not understanding how I am going to change the culture of mine and other companies that spend so many dollars on validation projects that drag on and on. In David’s world, he can complete a project in a week of planning and implementation; in my world, people spend the first week just letting the concept of a project sink in, and then maybe get started within a month or so. I’d like to be able to expedite projects in the way he has laid out; we’ll see how it goes.
- Sr. Validation Engineer

Electronic Signature topic was very valuable for me because we are implementing a document management system. The presenter is very knowledgeable; the amount of interaction between the participants and presenters was good.
- Information Technology Specialist

The course was well prepared. I like the "10 steps of validation" topic, I will apply this to all of my programs. It was great to make new connections, informal conversations with other participants during the networking hours was very beneficial. Speaker was very interactive. I will recommend this course and ComplianceOnline.com to others.
- IT Director

David was a dynamic presenter; I like his answers and interaction immensely. I really liked the session on "Reduction of Cost" and support materials.
- Project Manager

I really enjoyed the class. I thought the information that David Nettleton gave us was real world examples of the way Computer System Validation should be done. I have suggested to a few of my colleagues to review the information that we were given at the Computer System Validation Reduce Costs and Avoid 483.
The registration was an easy process. I forwarded the information to our Human Resources and they were able to handle it from the beginning.
- GCP Manager

I really appreciate the presentation given on topic "The 10 step approach". Overall program was well organized and coordinated. Experience with speaker was good, it was an engaging presentation. Informal conversation with other participant was beneficial.
- Assistant Manager of Technical Development

This was a very well seminar. The location, the food, the training material were all very much appreciated. David was a very charismatic, knows his stuff and presents the info in a way that making it entertaining.
- Software Quality Manager

Great dynamics between instructor and participants. The program was well organized and coordinated. Large amount of data was delivered in short time period.
- Engineering Electrical Controls Manager

Seminar was very good, informative and a lovely speaker making a tedious topic interesting. Overall the subjects are well chosen and the program was well organized and coordinated.
- Director - Global IT Governance

The training was excellent and I encountered no difficulties either with the registration process or during the event. This was one of the better trainings that I have attended over the years.
- Sr. QA Engineer

I thoroughly enjoyed the seminar! The content of the seminar was excellent and I would recommend it to others.
- Associate Director, Quality Operations

This was one of, if not the best, most informative, enjoyable trainings I've attended in my 11 year GMP career and I have been to many. David was simply an outstanding presenter. I think the thing that sets him apart from others, in addition to his obvious expertise and knowledge in computer validation, is that he is what today I feel is rare: a good teacher.
David as a teacher is very engaging. The normal nervousness of attendees has little chance of survival in David's class. He breaks through the ice, gets people comfortable and maintains a high level of professionalism. This creates an open atmosphere where people are free to think and ask questions. I generally am not afraid to ask questions and many times I feel alone in that. But in this class, there was much participation and people learn from other's questions. I attribute this to David's personality and approach to getting attendees involved.
In terms of improvements, the only thing I would change would be to have the lunch in a room where people could network (i.e. round tables) vs. coming back into the training room where you sat next to one person. The venue itself was great and the food was fantastic. The Ritz Carlton is a great location. Their service was also excellent.
Overall I had a very positive experience and brought back value to my company. I just wish I had more of a chance to network with the other attendees, although I did connect with a few.
- Lead Auditor/Sr. Laboratory Compliance Specialist

It was a very good experience, the presenter had very good knowledge on the topic but I would added more time to perform a “mini validation” using his templates so that more questions will come that will allow us to learn more.
He explained very well the concepts and gave good examples however is when we do things by our selves that we better understand and make the concepts "ours"
The place and lightening was fine, there was no noise interrupting.
- Software Validation Engineer

I was very confident in David Nettleton's knowledge on the subject matter.
- Research & Development Associate

I had registered for a seminar but unfortunately I was not able to attend. The company was very understanding and extremely helpful. I plan on attending a future event soon.
- Director of Regulatory Affairs, Nickell Physician & Pharmacy Services





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