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21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

From Friday, July, 13, 2018 to Friday, July, 13, 2018 in ca
Starting from:10:00

The Webinar 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 should you Attend: This Webinar 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

Who Will Benefit:

    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
    Any consultants working in the tobacco or life science industries who are involved in computer system implementation, validation and compliance

Speaker Profile
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.

Event link :
Contact Details:
NetZealous LLC, DBA compliance4All
Phone: +1-800-447-9407
Accreditations: 0
Concerned Public:
Attendance: International
Visitors/Participants: n.c
Speakers: n.c
Exhibitor: n.c
Event Type: Online Conference
Major Sector: BIOMEDICAL
Concerned sectors: Biomedical -Medical and Hospital Management -

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Congress, conferences or medical training REF #28-8104
21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
Published on on:2018-05-29 11:49:40
Congress, conferences or medical training in BIOMEDICAL
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