21 CFR Part 11 (Electronic Records/Electronic Signatures) Compliance for Computer Systems Regulated by FDA

By: Carolyn Troiano, ERP Project Manager/FDA Compliance Consultant.
Product code: SEM55
Location 1: Philadelphia Mar 11 - 12

Description

Course “Analytical Methods Validation and Transfer for FDA Compliance" has been Pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

"Each attendee will receive 2-Day workshop materials by the speaker. Seminar Also Includes Certificate, Complimentary Breakfast, Lunch & High Tea/Coffee provided by WCS"

The attendee will learn how to comply with FDA's 21 CFR Part 11 guidance, which addresses the use of electronic records and electronic signatures (ER/ES). There are specific security and authentication requirements that are not necessarily covered by the standard computer system validation (CSV) approach, and go somewhat beyond this.
We will also address the roles of people involved in validating and supporting the systems, aside from just the standard system users. There are many tasks and functions they need to understand in order to be in compliance.

Areas Covered

Upon completing this course participants should:
•          Understand FDA requirements for clinical trial Computer System Validation (CSV)
•          Understand the System Development Life Cycle (SDLC) approach to validation
•          Utilize GAMP 5 system classification and risk methodologies for categorizing systems and developing a validation pathway
•          Understand how to build a complete validation strategy and program for clinical trial systems
•          Know how to manage the validation process and create FDA-compliant documentation
•          Know how to monitor a clinical trial system that is in production, governing the data and system through retirement
•          Understand the roles and responsibilities required to validate a clinical trial system
•          Know how to measure cost vs. compliance risk for a clinical trial system
•          Understand good project management principles, incorporating business process re-engineering and organizational change management into the process
•          Know the policies and procedures that must be developed and maintained to support the clinical trial system in operation
•          Understand how to leverage the vendor and other external resources to apply the best industry practices and avoid potential pitfalls when validating a clinical trial system
•          Know about FDA trends in oversight and audit of clinical trial systems and how to keep abreast of these

Who will Benefit

•          Professionals in the following industries may also benefit from the content:
•          Pharmaceutical
•          Medical Diagnostics
•          Biotechnology
•          Tobacco and Related (Vapor, e-Cigarette, Cigar, etc.)
•          Animal Health
Any other FDA-regulated industry, plus any Life Science Consulting or Contracting firm
•          Information technology managers and analysts
•          Production managers and analysts
•          QC/QA managers and analysts
•          Clinical data managers and scientists
•          Compliance managers
•          Lab managers and staff
•          Automation analysts
•          Computer system validation specialists
•          GMP training specialists
•          Business stakeholders and individuals who are responsible for computer system validation planning, execution, reporting, compliance, training and audit
•          Consultants working in the life sciences, tobacco and related industries who are involved in computer system implementation, validation and compliance

Learning Objectives

Pharma , Medical Device & Biotech 

Course Outline:

(8:30 AM – 4:30 PM)

Day One:

Session 1. Introduction to FDA (4-49)
Session 2. 21 CFR Part 11/Annex 11 Compliance for Electronic Records and Electronic Signatures (50-114)
Session 3. The Five Keys to COTS Computer System Validation (115-139)
Session 4. The Validation Team (140-151)
Session 5. Preparing for an FDA Audit (152-168)
Session 6. COTS Risk-Based Computer System Validation Risk Assessment, Traceability Matrix (169-175)

 

(08:30 AM to 04:30 PM)

Day Two:

Session 7. How to Write Requirements and Specifications (176-188)
Session 8. How to Conduct a Hazard Analysis/ Risk Assessment – Exercise (189-199)
Session 9. Software Testing (200-208)
Session 10. System Change Control (209-214)
Session 11. Purchasing COTS Software (215-268)
Session 12. Cost Reduction Without Increasing Regulatory or Business Risk (269-362)

 

 

speaker

Carolyn TroianoERP Project Manager/FDA Compliance Consultant

Carolyn Troiano has more than 35 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.

11-March-2019 To 12-March-2019 Philadelphia
Seminar One Registration
$ 1596



Special Group Discount Register for Four attendees
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Testimonials

I have attended various seminars from WCS but this "Live" one was incredible. This seminar was excellent.

Pfizer Quality Manager

I liked WCS training style. WCS speakers gave excellent examples to back up what speaker was explaining. Which helped me grasp a better understanding."

RA/QA Manager Abbott

The presenter was excellent session leader, very knowledgeable and well-spoken. The topic was well chosen and interaction between the participants and the presenter was good.

Chief Compliance Officer
 

This was an informative seminar. Provided very valuable insight into how the FDA works. Presenters' experience in real life events and interaction with the FDA is priceless.

Quality Assurance Medtronic

“I enjoyed the training, the instructor was engaging and were able to modify the course to make it more applicable for small group.”

Peter Belsito, Director of Quality TSI

Awesome material covered.  Andbero Magleo, IT Admin Passy-Muir

“Very informative with enough details to start putting together action plans. Susan Murphy, Associate Director, Quality investigation (QA) LFB USA

“I learned a lot from the instructor and trainee good.” David QU, senior Analytical Chemist Dalton Pharma Services.

 

“Well placed, a lot of good information. Good interaction between participants. Held at a good location. More was US based examples given.” Nicola Mootoo, Senior Validation Engineer Shire Pharmaceuticals

 

“Well delivered seminars, right place, good contents.” Evelyn Chang, Corporate manager Genzyme.


“I though the contents of the presentation and the discussion was very good.”Mary Beird, Regulatory Compliance Manager Charles River laboratories International, Inc.

 

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It will help us audit and manage strategic HR issues.” The president of a major insurance and risk management agency.

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This session and ELLA seems to really fit the bill for us.” A human resource manager

 

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