Trends in FDA 2016 - Trends in FDA Compliance and Enforcement for Regulated Systems -By Compliance Global Inc

Overview:
Pharmaceutical, biological, vaccine, medical device, animal health, tobacco and other companies regulated by FDA must be vigilant in understanding compliance and enforcement by the Agency as it relates to computer system validation. In all cases, regulated companies should do the right thing and have robust computer system validation programs that are well executed and documented in order to meet the strict guidelines set forth by FDA compliance training.
At any given time, there will be areas the FDA focuses on more heavily, usually due to adverse events, or other issues that crop up within the regulated industries. In response, they may come down harder (or softer) in their enforcement practices.
Why Should You Attend:
Effective and compliant computer system validation is critical to any FDA-regulated organization. FDA has set forth very specific requirements for meeting compliance, and a very prescriptive set of enforcement actions to protect patient and/or consumer safety.
This webinar will enable you to best anticipate and prepare for FDA scrutiny, understand your role during inspections and audits, and gain insight to the level of enforcement associated with various findings, consent decrees and warning letters. Examples from industry will be used as case studies to illustrate these.
It is vital for regulated companies to maintain a pulse on the regulatory environment in order to fortify system validation efforts, as necessary, to meet FDA expectations.
It is the best practice to have a robust computer system validation, continue executing against it consistently, and documenting it thoroughly. By maintaining a strong and consistent computer system validation program, companies can further build trust with FDA and the consumers who rely on such oversight for protection.
Areas Covered in this Webinar:
Describe the various components of computer system validation compliance required by FDA
Understand the most critical aspects of computer systems to be scrutinized by FDA during reviews and audits
Discuss ways to anticipate and prepare for FDA scrutiny
Determine how identify and select the best course of action taken when responding to an FDA finding, warning or consent decree
Describe some of the key factors that influence the degree of FDA enforcement for system validation process in the GxP regulated industries
Discuss ways to apply basic computer system validation principles to ensure that in all cases a regulated company is prepared for emerging trends in patient safety
Provide examples of enforcement actions by FDA in industry, how companies have responded, and identify the best practices
Learning Objectives:
Understand FDA compliance and enforcement as it relates to computer system validation
Understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to FDA
Identify potential weaknesses and findings, as well as make recommendations for addressing and remediating them through risk mitigation
Who Will Benefit:
Information Technology Analysts
QC/QA Managers and Analysts
Clinical Data Managers and Scientists
Analytical Chemists
Compliance Managers
Lab Managers
Automation Analysts
Computer System Validation Specialists
GMP Training Specialists
Business Stakeholders
Individuals who are responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
Speaker Profile:
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.
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.
Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the PMI, AITP, RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.