Trends in FDA Compliance and Enforcement for Regulated Computer Systems

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

"Hear By Carolyn Troiano industry reviewer for 21 CFR Part 11, the FDA’s (ER/ES) regulation. along with computer system validation and risk management/compliance at a number of Fortune 100 firms."

Good Manufacturing, Laboratory and Clinical Practices

Description

DA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit.
As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA’s CFR Part 11 guidance on ER/ES must be followed.

This webinar will focus on the key areas that are most important, including security and data integrity. Implementing and following the System Development Life Cycle (SDLC) methodology is the best approach for computer system validation and maintaining data integrity. The life cycle approach takes all aspects of validation into account throughout the life of the system and the data that it houses. The data is a key asset for any FDA-regulated company and must be protected through its entire retention period.

Why should you attend 

FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. This guidance was first issued in 1983, and the main points of focus remain consistent today, despite the number of years that have passed and the technology changes that have taken place.
The guidance was revisited for its application to the medical device industry, as the first issuance addressed pharmaceuticals. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many laboratories and other FDA-regulated organizations began seeking ways to move into a paperless environment. This guidance has been modified over the years to make it more palatable to industry, and this includes discretionary enforcement measures. The intent was to avoid creating a huge regulatory compliance cost to industry that was initially preventing companies from embracing the technology.
This session will provide some insight into current trends in compliance and enforcement. Some are based on technology changes, and these will continue to have an impact as new innovations come into use in the industry.

Areas Covered

•        Learn about Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
•        Understand “GxP” Systems
•        Understand 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
•        Learn how Data Archival plays a key role in ensuring security, integrity and compliance
•        Learn how to develop a solid Validation Strategy that will take into account the system risk assessment and               system categorization (GAMP V) processes
•        Learn about recent FDA findings for companies in regulated industries
•        Learn about recent trends in technology that need to be addressed in the CSV approach 
•        Q&A

Who will Benefit


•         Pharmaceutical
•         Medical Device
•         Biotechnology
•         Tobacco and Related (Vapor, e-Cigarette, Cigar, etc.)
•         Any other FDA-regulated industry, plus any Life Science Consulting or Contracting firm
•         Information technology 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, and audit                                                    
•         Consultants working in the life sciences, tobacco and related industries who are involved in computer system              implementation, validation and compliance
•          Anyone involved in the planning, execution, and reporting of a clinical trial (sponsor, director, researcher,                    regulatory role, etc.)

Industries who can attend

This 90-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Carolyn Troiano

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.

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