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Event Details


21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

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Who should attend?

Clinical Data Managers and Scientists Analytical Chemists Laboratory Managers Automation Analysts


The seminar 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.

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 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 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
•    Policies and Procedures
•    Training and Organizational Change Management
•    Industry Best Practices and Common Pitfalls

Who Will Benefit:
You should attend this seminar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Examples of who will benefit from this seminar include:
•    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
This seminar will also benefit any consultants working in the tobacco or life science industries who are involved in computer system implementation, validation and compliance. 
Day 1 Schedule
Lecture 1 (90 Mins):
"GxP" Computer Systems and FDA Oversight
Lecture 2 (90 Mins):
Computer System Validation (CSV)
Lecture 3 (90 Mins):
System Development Life Cycle Management (SDLC) Methodology
Lecture 4 (90 Mins):
FDA's 21 CFR Part 11 (Electronic Records/Electronic Signatures) Guidance
Day 2 Schedule
Lecture 1 (90 Mins):
Strategic Approach to ER/ES Compliance
Lecture 2 (90 Mins):
Policies and Procedures to Support GxP Compliance with 21 CFR Part 11
Lecture 3 (90 Mins):
Training and Organizational Change Management Best Practices
Lecture 4 (90 Mins):
Industry Best Practices and Common Pitfalls

Carolyn 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.
Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.

Location:  Seattle, WA Date: September 6th & 7th, 2018 and Time: 9:00 AM to 6:00 PM
Venue:  Courtyard Seattle Sea-Tac Area 16038 West Valley Highway Tukwila Washington 98188 USA
Price: $1,495.00 (Seminar Fee for One Delegate) 
Register for 5 attendees Price: $4,485.00 $7,475.00 You Save: $2,990.00 (40%)* 
Register for 10 attendees Price: $8,222.00 $14,950.00 You Save: $6,728.00 (45%)*

Sponsorship Program benefits for seminar
For More Information- 

Contact us today!
NetZealous LLC DBA GlobalCompliancePanel
Toll free: +1-800-447-9407
Phone: +1-510-584-9661

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Price: $1,495.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $4,485.00 $7,475.00 You Save: $2,990.00 (40%)* Register for 10 attendees Price: $8,222.00 $14,950.00 You Save: $6,728.00 (45%)*


Event Manager

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