This strategy outfits you with bits of knowledge into your system and strategies for better basic leadership and basic reasoning.

The assembling business is one of the most tangled and requesting parts in light of the eccentrics of creation and tasks. Various associations attempt to unravel the systems to restrict the costs and addition the benefits. This in like manner fuses lessening the exercise in futility, endeavors, and stock. Thusly, it has ended up being basic to use information investigation and enormous information to be more information driven. This strategy outfits you with bits of knowledge into your system and strategies for better basic leadership and basic reasoning.

According to an ongoing Gartner examine, 80% of makers simply measure results. They measure past execution by investigating the results in the spending rundowns. To be sure, even the most relentless Lean Manufacturing Six Sigma Theory of Constraint specialists don’t have the foggiest thought what affected these results, or what is best done to improve proceeding.

On numerous occasions assembling firms, even top-level activities chiefs, use association investigations or reports which negligence to ask regarding why results failed. There is a thought to all elements consistently and also rather than seeing which region of a mechanical business needs most astuteness with respect to improving advantage.

Current industry examples exhibit that reception of Business Intelligence (BI) in organizations is on the rising with the more broad availability of BI programming just as the improvement of bleeding edge answers for handle enormous information. Various business methods are currently getting the opportunity to be mechanized, for instance, sending pamphlets to customers, making consistently deals reports, and amassing web based life experiences. In this manner, benefit and profitability are expanded, allowing SMEs to get a firmer solid footing in the market.

The assembling business is consistently changing a direct result of innovative improvements. Associations are searching for ways to deal with get an aggressive edge against their overall opponents. Information situated frameworks are supplanting the traditional ones. As associations are going up against a regularly expanding number of troubles, the enthusiasm for clear, information driven bits of knowledge is more unmistakable than whenever in late memory.

Assembling organizations are very information escalated in any case, consistently they are not prepared to use the data sagaciously. Gigantic piles of data falsehood inert with the associations. Business insight supports the capacity of these associations to use the assembled information in a productive way. BI can modify critical thinking and basic leadership. All of the territories of assembling gets changed in a beneficial way when BI steers.

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How to be Efficient and Compliant with Part 11, Validation, and SaaS/Cloud

Course “How to be Efficient and Compliant with Part 11, Validation, and SaaS/Cloud” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
  • 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.


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How to Reduce the Burden of Validation Documentation by Using Lean Documentation and Risk Assessment Best Practices

o Explain how to reduce the burden of validation documentation by using Lean Documentation & Risk Assessment Best Practices while still fully complying with regulations and achieving data integrity

Despite the criticality of Computer Systems Validation (CSV) and its related regulations on data integrity, such as 21 CFR and Annex 11; perhaps no company seems to be happy at the prospect of carrying out validation. Why is this so? It is because most companies that have reservations about validating computer systems in accordance with 21 CFR and Annex 11 don’t realize its importance.


Many organizations and regulatory professionals show resistance to CSV because they believe that this is a time-consuming and expensive exercise. Many believe that implementing CSV retards the deployment of many features and functions that could accelerate the organization’s business growth. Nothing is farther to the truth than this.

Patchwork solutions

It is a misconception that solutions such as commercial off-the-shelf (COTS) systems solve the issues relating to cost and productivity. COTS is at best an ad-hoc solution that is bought and installed on servers internally and then configured to suit the company’s corporate network and with other systems and databases and then used to manage it according to the company’s IT strategy and its SOPs. So, what is wrong with this system?

CSV-processNothing, except that when a company opts for COTS, the COTS vendor supplies only the COTS software package, which still leaves everything other than it with the ownership, management and maintenance by the company. The company still incurs significant costs on critical areas such as maintenance, administering the internal network connections, securing the data, creating disaster recovery contingencies and keeping the required hardware viable, which is very capital-intensive.

Most companies don’t realize that it is this, and not proper CSV, which slows down business functionality. This arrangement, with its inherently slow pace of deployment and functionality, keeps burgeoning, even as the resources needed for its implementation keep becoming lean, becoming inadequate to meeting business needs.

And what about the humongous blunder of documentation? This adds greater burden and could require redoing the whole thing if something goes wrong somewhere. In addition, most vendors use current technologies such as the cloud. Here, the vendor is in partial to near-total control. The automation techniques the vendor would use to update features and functions could sometimes clash with the current validation processes.

The solution

The solution is to get clarity on how to meet the same level of Quality that complying with regulations and GAMP 5 ensures, while taking advantage of technologies such as cloud and SaaS implementations, and to keep abreast of the latest technologies while ensuring the quality of computer systems and that they are “built to regulations” to achieve Data Integrity.

All aspects of validation explained

At this hands-on seminar, Angela will describe how the participants can speed up validation that is current in keeping up with recent technologies while still implementing a rigorous computerized system compliance program. She will show how to use the methodology enhancers of risk management, lean documentation and automated testing for ensuring this. She will explain how companies can achieve rigorous compliance, build computerized systems to regulations and use techniques that reduce the validation effort.

Also splashed into this seminar is a set of exercises that includes a project which the attendees are currently working on. Angela will also bring in a Jeopardy style quiz to test the attendees’ knowledge, and to also ensure maximum retention of the concepts and practices.

As a result of the learning gained at this seminar, attendees will be able to:

  • Master the principles and regulations that achieve data integrity by applying the 21 CFR 11/Annex 11 and GAMP 5 validation of computerized systems regulations to computerized systems
  • Explain how to reduce the burden of validation documentation by using Lean Documentation & Risk Assessment Best Practices while still fully complying with regulations and achieving data integrity
  • Explain automated testing best practices how to select automated testing vendors to ensure that use of vendor tools allows for the flexibility to use Cloud/SaaS/IaaS/PaaS related technologies while maintaining data integrity
  • Explain how to use Hardware Qualification and Change Control to manage both internal network and infrastructure as well as vendors such as cloud providers.

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