FDA Trends for Computer System Validation (CSV) Compliance and Enforcement (Boston, MA - June 25-26, 2018)

  • ID: 4535520
  • Conference
  • Location: Boston, MA
  • 2 Days
  • NetZealous LLC
  • Conference Dates: June 25-26, 2018
1 of 5

Course "FDA Trends for Computer System Validation (CSV) Compliance and Enforcement" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
FDA 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 seminar 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 seminar 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 you should attend:
FDA requires 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 in the Session:

  • Computer System Validation (CSV)
  • System Development Life Cycle (SDLC) Methodology
  • "GxP" - Good Manufacturing, Laboratory and Clinical Practices
  • 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
  • Data Archival to ensure security, integrity and compliance
  • Validation Strategy that will take into account the system risk assessment and system categorization (GAMP V) processes
  • Policies and Procedures
  • Critical Training
  • Recent FDA findings for companies in regulated industries
  • Recent trends in technology that need to be addressed in the CSV approach
  • Q&A
READ MORE
Note: Product cover images may vary from those shown
2 of 5

Day 1 Schedule

Lecture 1 (90 Mins):
Overview and Background: Computer System Validation (CSV)

Lecture 2 (90 Mins):
System Development Life Cycle (SDLC) Methodology

Lecture 3 (90 Mins):
GAMP 5 and Software Categorization

Lecture 4 (90 Mins):
System Risk Assessment and Management
Day 2 Schedule

Lecture 1 (90 Mins):
21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)

Lecture 2 (90 Mins):
Security and Access
Testing and Validation

Lecture 3 (90 Mins):
Policies and Procedures
Training and Expertise
Documentation

Lecture 4 (90 Mins):
Recent FDA findings for companies in regulated industries
Recent trends in technology that need to be addressed in the CSV approach
Q&A / Wrap-Up

Note: Product cover images may vary from those shown
3 of 5

Loading
LOADING...

4 of 5
  • Carolyn Troiano Carolyn Troiano,
    Business Systems Analyst ,
    Estes Express Lines


    Carolyn Troiano has more than 30 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.

Note: Product cover images may vary from those shown
5 of 5
  • Information Technology Analysts
  • QC/QA Managers
  • QC/QA Analysts
  • Clinical Data Managers
  • Clinical Data Scientists
  • Analytical Chemists
  • Compliance Managers
  • Laboratory Managers
  • Automation Analysts
  • Manufacturing Managers
  • Manufacturing Supervisors
  • Supply Chain Specialists
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders 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
  • Auditors engaged in the internal inspection of labeling records and practices
Note: Product cover images may vary from those shown
6 of 5

ADDRESS

Boston, MA

Venue to be announced shortly.

Note: Product cover images may vary from those shown
Adroll
adroll