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2-day In-person Seminar:
21 CFR Part 11 Compliance for Computer Systems Regulated by FDA Price Seattle, WA Price:
July 16th & 17th, 2018
$1,295.00
(Seminar for One Delegate)
9:00 AM to 6:00 PM Register now and save $200. (Early Bird)
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Carolyn Troiano
Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on FDA compliance, computer system validation and large-scale IT system implementation projects. Carolyn participated in the Industry/FDA partnership that developed 21 CFR Part 11, the FDA's guidance on electronic records and electronic signatures (ER/ES).
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Overview : The Seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDAregulated 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).
Global
CompliancePanel
2-day In-person Seminar: 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
Agenda: Day One
Day Two
Lecture 1 (90 Mins):
Lecture 1 (90 Mins):
“GxP" Computer Systems and FDA Oversight
Strategic Approach to ER/ES Compliance
Lecture 2 (90 Mins):
Lecture 2 (90 Mins):
Computer System Validation (CSV)
Policies and Procedures to Support GxP Compliance with 21 CFR Part 11
Lecture 3 (90 Mins): “System Development Life Cycle Management (SDLC) Methodology
Lecture 3 (90 Mins):
Lecture 4 (90 Mins):
Lecture 4 (90 Mins):
FDA's 21 CFR Part 11 (Electronic Records/Electronic Signatures) Guidance
Industry Best Practices and Common Pitfalls
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
Training and Organizational Change Management Best Practices
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
should be based on the specific case and the risk of
Electronic Records/Electronic Signatures (ER/ES)
failing to meet the guidance associated with it.
Security, Access, Change Control and Audit Trail Policies and Procedures Training and Organizational Change Management Industry Best Practices and Common Pitfalls
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
2-day In-person Seminar:
Global
CompliancePanel
21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
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