Source: https://www.compliance4all.com/control/w_product/~product_id=502783REC/~Carolyn_Troiano/~21_CFR_Part_11_Guidance_for_Electronic_Records_and_Electronic_Signatures_in_FDA-Regulated_Industries_
Timestamp: 2019-10-19 05:10:38
Document Index: 189328925

Matched Legal Cases: ['art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11']

21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries
Speakers All Steven Walfish Jeff Kasoff Teri C. Soli Miles Hutchinson Gina Lowdermilk Rodriguez Gonzalez Lynne Hare Donald Jones Norman G. Marriott Denise Cicchella Fred Vacelet Stuart Gardner Dev Raheja Stephen Alvania Jack Bleiberg Roger Nakata Anthony Goode Ms. Michael Redmond Reuven Rubinson Ray Kulzick James Bone Kenneth D. Simonson Anthony Kioussis Robert E. Davis Brian Perlberg John E Lincoln David Nettleton Robert J. Russell David R Dills Dr. Ludwig Huber Steven S. Kuwahara Melinda Allen Anna Longwell Lawrence F Muscarella Thomas E. Colonna Dan OLeary Robert Kunka Heath Rushing Albert A. Ghignone Elisa Harvey Rotimi Toki Randy Goodden Karl Leinsing Anne Tomalin Casper Uldriks Karen Greene Erin Hallenberg Jonathan M. Lewis Louis Angelucci Kenneth E. Arnold Leo Lagrotte Dr. Michael Forstner Anthony James Cuticchia Michael Brodsky John N. Zorich Hannes Wagner Joseph Habarta Herman Bozenhardt Drew Williamsen Michael Drues Adriaan Fruijtier Ricardo Valls Edward D. Mccullough Jerry Lanese Jerry Dalfors Jan Gates John Ryan Roger Bezdek David Ringstrom Mike Morley Jason Teliszczak Les Schnoll Buddy Baker Frank Cohen Karen Friedman Drew R Barnholtz Neal Machtiger Bernard Markstein Ronald Kudla Michael Allocco Andrew Hughes Drex Rutledge Betty Lane Alla Teresh Larry Spears Omid Khodai Mark Brengelman Angela Bazigos Richard Melancon Susan Brink Kim Huynh-Ba Shari Storm Carol Friedhoff Ron Rael Phil Edholm Majdi Ayoub Steve Yeger Brad Bossence Leonard Anastasi Chuck Gallagher Danny M. Goldberg Ben Neiburger Joseph Wolfe Heath Suddleson Stefan Graf Ted Garrison Sam DeMarco Jd Marhevko Cathy Dolan-Schweitzer Karl J Hemmerich Mark Pierson Ray Graber James Thatcher Harold Thibodeaux Christopher Hopkins Stephen Hull Glenda Guest Joy McElroy Jonnie T. Keith Jose Mora Robert Michalik Steven Wachs Dorothy D. Steed James E. Russell David Sanders Gregory J. Simms John R. Godshalk Robert K Minniti Greta Hicks Dr. Rossano V. Gerald John C. Fetzer Tim Stein Lynn Fountain Susanne Manz David N. Muchemu Dennis Taylor Howard Cooper Linda Cahan Richard Chamberlain Markus Weber Ronald Ramsdell Jay Hodes Edwin Waldbusser Mike Thomas Joe Rosner Charles H. Paul Peggy Berry Richard (Rick) K. Burdick Subhash Patel Jim Wisnowski Keith Warwick Thomas Perkins Dr. Annelie Struessmann Keith Gibbs Dr. Al Bartolucci Steven Laurenz Candace Leuck Rachelle D'Souza John E. Grimes Ginette Collazo Donna K Olheiser Lisa Marsden Jane Hennessy Salma Michor Dr. Charlie Sodano Rayleen M. Pirnie Kevin Chenoweth Danielle DeLucy Mary McDonald Brian Shoemaker Jed Constantz Tony Imm Greg Martin Vanessa Cozens Leonard Eisner Derk Yntema Douglas Cohen Deb Simpson Ruth Bell Valarie King Bailey Grant Smith Vanessa Lopez Hany Abou- El-Fotouh Eyal Lerner Carolyn Troiano Charles H Pierce Mika Reinikainen Brad Strahm Venkata Kashyap Yellepeddi Joe Lynch Roger Cowan Michael Abitz Nitika Sagar Thomas Bento Paul Lorcheim Gary Miller Stephanie Cooke Laura Brown Stefan Menzl Gary Bird Lena Cordie Wava Truscott Michele Pfannenstiel Dr. David Lim Lamont M. Fulton Eleonora Babayants Michael Esposito Shib Mookherjea Shep Bentley Dr. Saeed Qureshi Marina Malikova George Gasparis Sheldon Primus Lauren Neighbours Michael Aust Thomas Nollner Grace Morgan Holmes Christina Bernstein Jack Dhuwalia Tom Fragale Yingying Liu Tim Lombardo Rita Hoffman Amer Alghabban Tom Parke Dr. Afsaneh Motamed Khorasani Emil W Ciurczak Wayne Taylor John Chapman Dr. Shuguang Huang Dr. Subodh Bhardwaj Carly Souther Ben Woodcock Dr. Robert North Kelly Thomas Todd B. Graham Prof. Dr. h.c. Frank Stein Susanne Picard Gwendolyn Wise-Blackman Deidre Tate Gina Reo Joseph P. ("Joe") McMenamin MaryAnn Lawrence Robert (Bob) Uleski Dr. Bart Basi Peter Vishton P.E. William D Fox Willy Vandenbrande Steve Gompertz Swasita Saigal Perry Saidman Yuval Shapiro Martin K. Behr, III Allecia Harley Shiron Vick Nancy Knettell
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.
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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.
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.
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.
System Development Life Cycle (SDLC) Methodology
Good "Variable" Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
GAMP 5 "V" Model
Compliance Managers and Auditors
Lab Managers and Analysts
Business Stakeholders using Computer Systems regulated by FDA
Consultants in the Life Sciences and Tobacco Industries
Interns working at the companies listed above
College students attending schools and studying computer system validation, regulatory affairs/matters (related to FDA) or any other discipline that involves adherence to FDA regulatory requirements
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.