BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240319T025316Z UID:8ed8a8e8-d5d3-4e44-9fa5-065aa4880ec7 DTSTART:20210127T090000 DTEND:20210128T090000 CLASS:PRIVATE DESCRIPTION:\n
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The Webinar will focus on the importance of ensurin g that electronic record/electronic signature (ER/ES) capability built int o FDA-regulated computer systems meets compliance with 21 CFR Part 11. Thi s includes development of a company philosophy and approach\, and incorpor ating it into the overall computer system validation program and plans for individual systems that have this capability.
\n\nFDA'\;s 21 CFR Part 11 was enacted in the late 1990 s 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 o f users that ensures the person signing the record is the same person whos e credentials are being entered and verified by the system. Rule for chang ing passwords must be rigorously adhered to and the passwords must be kept secure.
\n\nIt is also critica l that the system specify the exact meaning of the signature. It may be th at the person conducted the work\, recorded the result\, reviewed the resu lt\, 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).< /span>
\n\nA company must have specifi c policies and procedures in place that explicitly state responsibilities and provide guidance for implementing and using ER/ES capability. These mu st clarify the 21 CFR Part 11 regulation and provide insight as to the way the company interprets their responsibility for meeting it. As FDA contin ues to evolve and change due to the many factors that influence the regula tory environment\, companies must be able to adapt. New technologies will continue to emerge that will change the way companies do business. While m any of these are intended to streamline operations\, reducing time and res ources\, some unintentionally result in added layers of oversight that enc umber a computer system validation program and require more time and resou rces\, making the technology unattractive from a cost-benefit perspective.
\n\nThis seminar will he lp you understand in detail the application of FDA'\;s 21 CFR Part 11 g uidance on electronic records/electronic signatures (ER/ES) for computer s ystems subject to FDA regulations. This is critical in order to develop th e appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a s ystem is maintained in a validated state throughout its entire life cycle\ , from conception through retirement.
\n\nER/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.
\n\nYou should attend this webinar if you are responsible for planning\, e xecuting or managing the implementation of any system governed by FDA regu lations\, or if you are maintaining or supporting such a system. Examples of who will benefit from this webinar include:
\n\nThis webinar will also benefi t any consultants working in the tobacco or life science industries who ar e involved in computer system implementation\, validation and compliance.< /span>
\n\n \;
\n\nLecture 1:< /span>
\n"\;GxP"\; Comput er Systems and FDA Oversight\n\nLecture 2:
\nLecture 3:
\n System Development Life Cycle Management (SDLC) Methodology\n\nLecture 4:
\nFDA'\;s 21 CFR Part 11 (Electr onic Records/Electronic Signatures) Guidance\n\nLecture 1:
\n Strategic Approach to ER/ES Compliance\n\nLecture 2:
\nPolicies and Procedures to Support GxP Compliance with 21 CFR Part 11\n\nLecture 3:
\nTraining an d Organizational Change Management Best Practices\n\nLecture 4:
\nIndustry Best Practices and Common PitfallsCarolyn Troiano has more than 35 years of experience in the tobacco\, pharmaceutical\, medical device and other FDA-regulated industries. She ha s worked directly\, or on a consulting basis\, for many of the larger phar maceutical and tobacco companies in the US and Europe\, developing and exe cuting compliance strategies and programs.
\n\nCarolyn is currently active in the Association of Informat ion Technology Professionals (AITP)\, and Project Management Institute (PM I) chapters in the Boston\, MA area.
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\n\nPlease contact the event manager Marilyn below
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rticipants.
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\n\n \; SUMMARY:21 CFR Part 11 Compliance for Computer Systems Regulated by FDA (nt z) BEGIN:VALARM ACTION:DISPLAY TRIGGER:-PT1H SUMMARY:21 CFR Part 11 Compliance for Computer Systems Regulated by FDA (nt z) END:VALARM END:VEVENT END:VCALENDAR