21 CFR Part 11 Compliance for Computer Systems Regulated by FDA (Seattle, WA - July 16-17, 2018)

  • ID: 4535721
  • Conference
  • Location: Seattle, WA
  • 2 Days
  • NetZealous
  • Conference Dates: July 16-17, 2018
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Course "21 CFR Part 11 Compliance for Computer Systems Regulated by FDA" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall Computer System Validation program and plans for individual systems that have this capability.

FDA's 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries has been mixed. There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system. Rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.

It is also critical that the system specify the exact meaning of the signature. It may be that the person conducted the work, recorded the result, reviewed the result, or approved the result. A person may simply be attesting to the fact that they reviewed the work and the signatures, and there was appropriate segregation of duties (i.e., the person recording the result is not the same as either the person reviewing or the person giving final approval).

A company must have specific policies and procedures in place that explicitly state responsibilities and provide guidance for implementing and using ER/ES capability. These must clarify the 21 CFR Part 11 regulation and provide insight as to the way the company interprets their responsibility for meeting it. As FDA continues to evolve and change due to the many factors that influence the regulatory environment, companies must be able to adapt. New technologies will continue to emerge that will change the way companies do business. While many of these are intended to streamline operations, reducing time and resources, some unintentionally result in added layers of oversight that encumber a Computer System Validation program and require more time and resources, making the technology unattractive from a cost-benefit perspective.

Why you should attend:
This seminar will help you understand in detail the application of FDA's 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.
ER/ES capability can vary, and the approach should be based on the specific case and the risk of failing to meet the guidance associated with it.

Areas Covered in the Session:

  • Computer System Validation (CSV)
  • System Development Life Cycle (SDLC) Methodology
  • Good "Variable" Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
  • Validation Strategy
  • System Risk Assessment
  • GAMP 5 "V" Model
  • 21 CFR Part 11
  • Electronic Records/Electronic Signatures (ER/ES)
  • Security, Access, Change Control and Audit Trail
  • Policies and Procedures
  • Training and Organizational Change Management
  • Industry Best Practices and Common Pitfalls
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Day 1 Schedule

Lecture 1 (90 Mins):
"GxP" Computer Systems and FDA Oversight

Lecture 2 (90 Mins):
Computer System Validation (CSV)

Lecture 3 (90 Mins):
System Development Life Cycle Management (SDLC) Methodology

Lecture 4 (90 Mins):
FDA's 21 CFR Part 11 (Electronic Records/Electronic Signatures) Guidance

Day 2 Schedule

Lecture 1 (90 Mins):
Strategic Approach to ER/ES Compliance

Lecture 2 (90 Mins):
Policies and Procedures to Support GxP Compliance with 21 CFR Part 11

Lecture 3 (90 Mins):
Training and Organizational Change Management Best Practices

Lecture 4 (90 Mins):
Industry Best Practices and Common Pitfalls

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  • Carolyn Troiano Carolyn Troiano,
    Business Systems Analyst ,
    Estes Express Lines


    Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.

    During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA’s electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.

    Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.

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You should attend this seminar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Examples of who will benefit from this seminar include:

  • Information Technology Analysts
  • Information Technology Developers and Testers
  • QC/QA Managers and Analysts
  • Clinical Data Managers and Scientists
  • Analytical Chemists
  • Laboratory Managers
  • Automation Analysts
  • Manufacturing and Supply Chain Managers and Analysts
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders/Subject Matter Experts in FDA-Regulated Functional Areas
  • Business System/Application Testers in FDA-Regulated Functional Areas

This seminar will also benefit any consultants working in the tobacco or life science industries who are involved in computer system implementation, validation and compliance. 

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ADDRESS

Seattle, WA

Venue to be announced shortly.

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