21 CFR Part 11 Guidance on Electronic Records and Electronic Signatures for Computer Systems Regulated by FDA
Carolyn Troiano is Keynote Speaker at ComplianceKey.She has more than 30 years of experience during which she worked directly, or as a consultant, for many top-tier pharmaceutical, medical device and biological companies in the US and Europe. She was responsible for computer system validation compliance activities across all GxP functions at a major pharmaceutical company. She developed computer system validation programs and strategies and was an industry reviewer for 21 CFR Part 11, the FDA's electronic record/electronic signature (ER/ES) regulation. Carolyn has participated in industry conf........
Overview
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.
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.
Why should you attend this webinar?
You should attend this seminar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations that uses ER/ES capability, or if you are maintaining or supporting such a system.
Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. During the past 30 years, best practices that have been developed will ensure that validation activities are cost-effective while meeting all aspects of FDA compliance.
There is an enormous body of documentation and information available that can be overwhelming. This course will provide a condensed overview of the key practices that deliver the best results by directing the attendees to the most critical and cost-effective methods, techniques and tools available.
Areas Covered in the Session:
This webinar will cover the following key areas:
- Gain an understanding of FDA's 21 CFR Part 11 Electronic Records/Electronic Signatures (ER/ES) guidance document
- Develop the ability to apply 21 CFR Part 11 when implementing, validating and maintaining computer systems in your organization
- Understand the best practices for maintaining a computer system with ER/ES capability in a validated state
- Discuss the best practices necessary to ensure all systems with ER/ES capability are validated appropriately
- Learn how to develop the appropriate computer validation strategy, to ensure a good balance of cost vs. risk, as it applies to the use of ER/ES capability
- Understand how to effectively document the process of computer system validation where ER/ES capability exists, and maintain current information about the various systems in your organization and how they are maintained in a validated state
- Learn how to gain information about trends in ER/ES validation, as industry progresses and new best practices emerge
- Understand some of the key "pitfalls" to avoid when employing ER/ES capability
- Q&A
Who can Benefit:
Industry:
- Pharmaceutical
- Medical Device
- Biotechnology
- Software Development for FDA-Regulated Industries
- Tobacco, Tobacco-related products (cigars, e-cigarettes, e-liquids, etc.)
Role/Designation:
- Within FDA-regulated companies, people in the following roles will benefit from this presentation:
- Computer System Validation Specialists
- Information Technology Professionals
- Automation Analysts and Managers
- QC/QA Analysts and Managers
- Laboratory Analysts and Managers
- Clinical Data Analysts and Managers
- Manufacturing Analysts and Supervisors
- Supply Chain Managers and Analysts
- Compliance and Audit Managers
- GMP Training Specialists
- Regulatory Affairs Professionals
- Business Stakeholders/Subject Matter Experts
- Business System/Application Testers
Anyone who is involved in the development, testing, manufacturing, storage, handling and distribution of product must understand and conform to FDA requirements for computer system validation.
Finally, anyone who is acting as a consultant or contractor to a company in an FDA-regulated industry should attend to ensure they are able to bring the most current knowledge and expertise to their assignment.
Webinar Id: LSHCCT0020
Past Webinar of Carolyn Troiano
